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Absorb GT1 Japan PMS

Primary Purpose

Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
ABSORB GT1 BVS
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Heart Disease focused on measuring Drug eluting Bio-resolvable Scaffold (BRS), Bio-resolvable Scaffold (BRS), Real world

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • General Percutaneous coronary intervention (PCI) population.

Exclusion Criteria:

  • No specific exclusion criteria.

Sites / Locations

  • Nagoya Daini Red Cross Hospital
  • Shin Tokyo Hospital
  • Shin Koga Hospital
  • Hanaoka Seishu Memorial Cardiovascular Clinic
  • Kobe University
  • Iwate Medical University
  • Shonan Kamakura General Hospital
  • Kurashiki Central Hospital
  • Saitama Sekishinkai Hospital
  • Mitsui Memorial Museum
  • Teikyo University
  • Toho University Ohashi Medical Center
  • Saiseikai Kumamoto Hospital
  • Miyazaki Medical Association Hospital
  • Sakurabashi Watanabe Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Absorb GT1 BVS

Arm Description

Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.

Outcomes

Primary Outcome Measures

Number of Participants With Acute Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Sub Acute Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Very Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Overall Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Exclusion of Very Small Vessels
For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD < 2.5 mm from registration by the last half of Phase 1.
Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging
IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.
Number of Participants With Composite of Device Deficiencies
Device deficiencies: Number of participants with at least one of the following Device deficiencies Lesion/implant failure Delivery difficulty (finally delivered) Re-crossing failure Re-crossing difficulty Post-dilatation balloon Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) Instruction for Use (IFU) not included Major Strut Malapposition Strut Fracture within 6 months
Number of Participants With Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Very Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation

Secondary Outcome Measures

Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Angiographic Endpoints (Core Lab Analysis): Lesion Morphology
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
Angiographic Endpoints (Core Lab Analysis): Lesion Length
Lesion Length (can be measured after successful post-dilatation)
Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)
Proximal RVD (can be measured after successful post-dilatation)
Angiographic Endpoints (Core Lab Analysis): Distal RVD
Distal RVD (can be measured after successful post-dilatation)
Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen
Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition
Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture
Strut fracture will be measured as either number or percentage post-procedure
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Full Information

First Posted
May 18, 2017
Last Updated
July 18, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT03409731
Brief Title
Absorb GT1 Japan PMS
Official Title
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2016 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
February 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion, Myocardial Ischemia
Keywords
Drug eluting Bio-resolvable Scaffold (BRS), Bio-resolvable Scaffold (BRS), Real world

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Absorb GT1 BVS
Arm Type
Other
Arm Description
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Intervention Type
Device
Intervention Name(s)
ABSORB GT1 BVS
Intervention Description
Patients receiving Absorb GT1 BVS
Primary Outcome Measure Information:
Title
Number of Participants With Acute Scaffold Thrombosis (ST)
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
Day 0
Title
Number of Participants With Sub Acute Scaffold Thrombosis (ST)
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
>1 to 30 days
Title
Number of Participants With Late Scaffold Thrombosis (ST)
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
31 to 90 days
Title
Number of Participants With Late Scaffold Thrombosis (ST)
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
31 to 365 days
Title
Number of Participants With Very Late Scaffold Thrombosis (ST)
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
366 to 730 days
Title
Number of Participants With Overall Scaffold Thrombosis (ST)
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
0 to 90 days
Title
Number of Participants With Cumulative Scaffold Thrombosis
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
0 to 90 days
Title
Number of Participants With Cumulative Scaffold Thrombosis
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
0 to 730 days
Title
Number of Participants With Exclusion of Very Small Vessels
Description
For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD < 2.5 mm from registration by the last half of Phase 1.
Time Frame
During index procedure, "54.8 ± 27.6 min"
Title
Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging
Description
IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.
Time Frame
During index procedure, "54.8 ± 27.6 min"
Title
Number of Participants With Composite of Device Deficiencies
Description
Device deficiencies: Number of participants with at least one of the following Device deficiencies Lesion/implant failure Delivery difficulty (finally delivered) Re-crossing failure Re-crossing difficulty Post-dilatation balloon Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) Instruction for Use (IFU) not included Major Strut Malapposition Strut Fracture within 6 months
Time Frame
During index procedure, "54.8 ± 27.6 min"
Title
Number of Participants With Late Scaffold Thrombosis (ST)
Description
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation.
Time Frame
731 - 1095 days
Title
Number of Participants With Cumulative Scaffold Thrombosis
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
0 - 1095 days
Title
Number of Participants With Very Late Scaffold Thrombosis (ST)
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
1096 - 1460 days
Title
Number of Participants With Cumulative Scaffold Thrombosis
Description
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame
0 - 1460 days
Secondary Outcome Measure Information:
Title
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 30 days
Title
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 90 days
Title
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 1 year
Title
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 2 years
Title
Number of Participants With All Myocardial Infarction (MI)
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time Frame
0 to 30 days
Title
Number of Participants With All Myocardial Infarction (MI)
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time Frame
0 to 90 days
Title
Number of Participants With All Myocardial Infarction (MI)
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time Frame
0 to 1 year
Title
Number of Participants With All Myocardial Infarction (MI)
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time Frame
0 to 2 years
Title
Number of Participants With All Target Lesion Revascularization (TLR)
Description
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time Frame
0 to 30 days
Title
Number of Participants With All Target Lesion Revascularization (TLR)
Description
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time Frame
0 to 90 days
Title
Number of Participants With All Target Lesion Revascularization (TLR)
Description
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time Frame
0 to 1 year
Title
Number of Participants With All Target Lesion Revascularization (TLR)
Description
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time Frame
0 to 2 years
Title
Number of Participants With All Target Vessel Revascularization (TVR)
Description
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame
0 to 30 days
Title
Number of Participants With All Target Vessel Revascularization (TVR)
Description
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame
0 to 90 days
Title
Number of Participants With All Target Vessel Revascularization (TVR)
Description
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame
0 to 1 year
Title
Number of Participants With All Target Vessel Revascularization (TVR)
Description
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame
0 to 2 years
Title
Number of Participants With All Coronary Revascularization
Description
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time Frame
0 to 30 days
Title
Number of Participants With All Coronary Revascularization
Description
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time Frame
0 to 90 days
Title
Number of Participants With All Coronary Revascularization
Description
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time Frame
0 to 1 year
Title
Number of Participants With All Coronary Revascularization
Description
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time Frame
0 to 2 years
Title
Number of Death/MI/All Revascularization (DMR)
Description
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame
0 to 30 days
Title
Number of Death/MI/All Revascularization (DMR)
Description
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame
0 to 90 days
Title
Number of Death/MI/All Revascularization (DMR)
Description
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame
0 to 1 year
Title
Number of Death/MI/All Revascularization (DMR)
Description
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame
0 to 2 years
Title
Number of Participants With Target Vessel Failure (TVF)
Description
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame
0 to 30 days
Title
Number of Participants With Target Vessel Failure (TVF)
Description
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame
0 to 90 days
Title
Number of Participants With Target Vessel Failure (TVF)
Description
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Time Frame
0 to 1 Year
Title
Number of Participants With Target Vessel Failure (TVF)
Description
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Time Frame
0 to 2 years
Title
Number of Major Adverse Cardiac Event (MACE)
Description
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time Frame
0 to 30 days
Title
Number of Major Adverse Cardiac Event (MACE)
Description
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time Frame
0 to 90 days
Title
Number of Major Adverse Cardiac Event (MACE)
Description
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time Frame
0 to 1 year
Title
Number of Major Adverse Cardiac Event (MACE)
Description
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time Frame
0 to 2 years
Title
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
0 to 30 days
Title
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
0 to 90 days
Title
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
0 to 1 year
Title
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
0 to 2 years
Title
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame
0 to 30 days
Title
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame
0 to 90 days
Title
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame
0 to 1 year
Title
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame
0 to 2 years
Title
Angiographic Endpoints (Core Lab Analysis): Lesion Morphology
Time Frame
Pre-procedure
Title
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
Description
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
Time Frame
Pre-procedure
Title
Angiographic Endpoints (Core Lab Analysis): Lesion Length
Description
Lesion Length (can be measured after successful post-dilatation)
Time Frame
Pre-procedure
Title
Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)
Description
Proximal RVD (can be measured after successful post-dilatation)
Time Frame
Pre-procedure
Title
Angiographic Endpoints (Core Lab Analysis): Distal RVD
Description
Distal RVD (can be measured after successful post-dilatation)
Time Frame
Pre-procedure
Title
Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)
Description
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen
Time Frame
Pre-procedure
Title
Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)
Description
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame
Pre-procedure
Title
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
Description
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
Time Frame
Post-procedure (average procedure time of "54.8 ± 27.6 min")
Title
Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)
Description
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Time Frame
Post-procedure (average procedure time of "54.8 ± 27.6 min")
Title
Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )
Description
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Time Frame
Post-procedure (average procedure time of "54.8 ± 27.6 min")
Title
Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )
Description
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Time Frame
Post-procedure (average procedure time of "54.8 ± 27.6 min")
Title
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
Time Frame
Pre-procedure (or after pre-dilatation)
Title
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
Time Frame
Post-procedure (average procedure time of "54.8 ± 27.6 min")
Title
IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area
Time Frame
Post-procedure (average procedure time of "54.8 ± 27.6 min")
Title
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition
Description
Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure
Time Frame
Post-procedure (average procedure time of "54.8 ± 27.6 min")
Title
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture
Description
Strut fracture will be measured as either number or percentage post-procedure
Time Frame
Post-procedure (average procedure time of "54.8 ± 27.6 min")
Title
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
3 years
Title
Number of Participants With All Myocardial Infarction (MI)
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time Frame
3 years
Title
Number of Participants With All Target Lesion Revascularization (TLR)
Description
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time Frame
3 years
Title
Number of Participants With All Target Vessel Revascularization (TVR)
Description
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame
3 years
Title
Number of Participants With All Coronary Revascularization
Description
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time Frame
3 years
Title
Number of Death/MI/All Revascularization (DMR)
Description
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame
3 years
Title
Number of Participants With Target Vessel Failure (TVF)
Description
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame
3 years
Title
Number of Major Adverse Cardiac Event (MACE)
Description
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time Frame
3 years
Title
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
3 years
Title
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame
3 years
Title
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
4 years
Title
Number of Participants With All Myocardial Infarction (MI)
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time Frame
4 years
Title
Number of Participants With All Target Lesion Revascularization (TLR)
Description
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time Frame
4 years
Title
Number of Participants With All Target Vessel Revascularization (TVR)
Description
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame
4 years
Title
Number of Participants With All Coronary Revascularization
Description
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time Frame
4 years
Title
Number of Death/MI/All Revascularization (DMR)
Description
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame
4 years
Title
Number of Participants With Target Vessel Failure (TVF)
Description
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame
4 years
Title
Number of Major Adverse Cardiac Event (MACE)
Description
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time Frame
4 years
Title
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
4 years
Title
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Description
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame
4 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: General Percutaneous coronary intervention (PCI) population. Exclusion Criteria: No specific exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masato Nakamura, MD
Organizational Affiliation
Toho University Ohashi Medical Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nagoya Daini Red Cross Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Shin Tokyo Hospital
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
270-2232
Country
Japan
Facility Name
Shin Koga Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-8577
Country
Japan
Facility Name
Hanaoka Seishu Memorial Cardiovascular Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
062-0003
Country
Japan
Facility Name
Kobe University
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Iwate Medical University
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Saitama Sekishinkai Hospital
City
Sayama
State/Province
Saitama
ZIP/Postal Code
350-1323
Country
Japan
Facility Name
Mitsui Memorial Museum
City
Chiyoda
State/Province
Tokyo
ZIP/Postal Code
101-8643
Country
Japan
Facility Name
Teikyo University
City
Itabashi
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Meguro
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Miyazaki Medical Association Hospital
City
Miyazaki
ZIP/Postal Code
880-0834
Country
Japan
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes

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