Back to resultsXIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Primary Purpose
Coronary Occlusion, Thrombosis (Stent Thrombosis), Vascular Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
XIENCE V EECSS
CYPHER SELECT PLUS SECSS
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Occlusion focused on measuring Drug eluting stents, Stents, Angioplasty
Eligibility Criteria
Inclusion Criteria:
General Inclusion Criteria
- Patient must be at least 18 years of age
- The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee (EC)-approved ICF prior to procedure.
- Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.
- Patient must not currently be and must agree not to become a participant in any other clinical trial until completion of his/her 2-year follow-up.
Angiographic Inclusion Criteria
- Target lesion(s) must be located in a native de novo coronary artery with a visually estimated diameter between ≥ 2.25 and ≤ 4.0 mm.
- Target lesion(s) must measure ≤ 28 mm in length by visual estimation.
A maximum of two de novo lesions can be treated, ie,
- One lesion in one vessel, OR
- One lesion in each of two vessels, OR
- Two lesions in one vessel
Exclusion Criteria:
General Exclusion Criteria
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure
- Patients with known renal insufficiency or failure (eg, serum creatinine level of > 2.5 mg/dL, or patient is on dialysis)
- Patient had an MI within 72 hours and creatine kinase-myocardial band isoenzyme (CK-MB) has not returned to the normal range at the index procedure
- Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure
- Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure
- Left ventricular ejection fraction (LVEF) of < 30%.
- Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year
- Patient's current medical condition has a life expectancy of < 2 years
- Patient meets contraindications of the IFU
Angiographic Exclusion Criteria
- Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
- Lesion located in left main coronary artery
- Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries)
- Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation
- Total occluded lesions (TIMI=0)
- Restenotic lesions
- Thrombus-containing vessel
- Extreme angulation (≥ 90º) proximal to or within the lesion
- Excessive tortuosity proximal to or within the lesion
- Heavy calcification
Sites / Locations
- Fu Wai Hospital
- Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
XIENCE V EECSS
CYPHER SELECT PLUS SECSS
Arm Description
Patients who will receive this stent.
Patients who will receive this stent.
Outcomes
Primary Outcome Measures
In-stent Late Loss (LL)
This is the primary angiographic endpoint.
In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)
Ischemia-driven Target Vessel Failure (ID-TVF)
This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).
Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave).
Secondary Outcome Measures
Ischemia-driven Target Vessel Failure (ID-TVF)
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])
Ischemia-driven Target Vessel Failure (ID-TVF)
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]).
Ischemia-driven Target Vessel Failure (ID-TVF)
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])
Ischemia-driven Target Vessel Failure (ID-TVF)
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])
The is the major Secondary Efficacy Endpoint.
Ischemia-driven Target Lesion Failure (ID-TLF)
Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Ischemia-driven Target Lesion Failure (ID-TLF)
Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Ischemia-driven Target Lesion Failure (ID-TLF)
This is one of the Secondary Composite Endpoints.
Ischemia-driven Target Lesion Failure (ID-TLF)
This is one of the Secondary Composite Endpoints.
Ischemia-driven Target Lesion Failure (ID-TLF)
This is one of the Secondary Composite Endpoints.
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
All Revascularization (TLR, TVR, and Non-TVR)
All Revascularization (TLR, TVR, and Non-TVR)
All Revascularization (TLR, TVR, and Non-TVR)
All Revascularization (TLR, TVR, and Non-TVR)
All Revascularization (TLR, TVR, and Non-TVR)
One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
All Death
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
All Protocol MI (Including Q-wave or Non-Q-wave)
This is one of the secondary safety endpoint.
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Target Vessel Protocol MI (TV-MI)
This is one of the secondary safety endpoint.
Major Bleeding Complications
Secondary safety endpoint.
Major Bleeding Complications
Secondary safety endpoint.
Major Bleeding Complications
Secondary safety endpoint.
Major Bleeding Complications
Secondary safety endpoint.
Major Bleeding Complications
Secondary safety endpoint.
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Definite / Probable Stent Thrombosis
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Acute Device Success
Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of < 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.
Acute Procedure Success
Per-protocol procedure success is defined as the achievement of a final in-stent DS of < 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non-Q-wave), or repeat revascularization of the target lesion during the hospital stay.
Procedure Time
This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.
Amount of Contrast Used
Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.
Fluoroscopy Time
This is the procedure related endpoint.
XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire
A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure.
Follow-up Late Loss
This is one of the Secondary Angiographic Endpoint.
Follow-up In-stent Minimum Lumen Diameter (MLD)
Follow-up In-stent Percent Diameter Stenosis (DS)
Follow-up In-stent Angiographic Binary Restenosis (ABR)
Follow-up In-segment Minimum Lumen Diameter (MLD)
Follow-up In-segment Percent Diameter Stenosis (DS)
Follow-up In-segment Angiographic Binary Restenosis (ABR)
Percent Diameter Stenosis
Percent Diameter Stenosis (%DS)
Acute Gain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01178268
Brief Title
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Official Title
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during commercial use in China.
Detailed Description
Objectives
Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China
Evaluate patient compliance with dual antiplatelet therapy (DAPT)
Evaluate physician-determined XIENCE V EECSS acute performance, deliverability, and resource utilization
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Occlusion, Thrombosis (Stent Thrombosis), Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Keywords
Drug eluting stents, Stents, Angioplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
546 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XIENCE V EECSS
Arm Type
Active Comparator
Arm Description
Patients who will receive this stent.
Arm Title
CYPHER SELECT PLUS SECSS
Arm Type
Active Comparator
Arm Description
Patients who will receive this stent.
Intervention Type
Device
Intervention Name(s)
XIENCE V EECSS
Intervention Description
Patients who will receive this stent.
Intervention Type
Device
Intervention Name(s)
CYPHER SELECT PLUS SECSS
Intervention Description
Patients who will receive this stent.
Primary Outcome Measure Information:
Title
In-stent Late Loss (LL)
Description
This is the primary angiographic endpoint.
In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)
Time Frame
>=13 months
Title
Ischemia-driven Target Vessel Failure (ID-TVF)
Description
This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).
Time Frame
12 months
Title
Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Description
The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Ischemia-driven Target Vessel Failure (ID-TVF)
Description
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])
Time Frame
30 days
Title
Ischemia-driven Target Vessel Failure (ID-TVF)
Description
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]).
Time Frame
6 months
Title
Ischemia-driven Target Vessel Failure (ID-TVF)
Description
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])
Time Frame
9 months
Title
Ischemia-driven Target Vessel Failure (ID-TVF)
Description
Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])
Time Frame
24 months
Title
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).
Time Frame
30 days
Title
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).
Time Frame
6 months
Title
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Time Frame
9 months
Title
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Time Frame
24 months
Title
Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])
Description
The is the major Secondary Efficacy Endpoint.
Time Frame
12 months
Title
Ischemia-driven Target Lesion Failure (ID-TLF)
Description
Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Time Frame
30 days
Title
Ischemia-driven Target Lesion Failure (ID-TLF)
Description
Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Time Frame
6 months
Title
Ischemia-driven Target Lesion Failure (ID-TLF)
Description
This is one of the Secondary Composite Endpoints.
Time Frame
9 months
Title
Ischemia-driven Target Lesion Failure (ID-TLF)
Description
This is one of the Secondary Composite Endpoints.
Time Frame
12 months
Title
Ischemia-driven Target Lesion Failure (ID-TLF)
Description
This is one of the Secondary Composite Endpoints.
Time Frame
24 months
Title
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame
30 days
Title
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame
6 months
Title
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame
9 months
Title
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame
12 months
Title
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame
24 months
Title
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame
30 days
Title
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame
6 months
Title
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame
9 months
Title
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame
12 months
Title
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description
This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame
24 months
Title
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame
30 days
Title
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame
6 months
Title
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame
9 months
Title
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame
12 months
Title
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame
24 months
Title
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame
30 days
Title
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame
6 months
Title
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame
9 months
Title
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame
12 months
Title
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame
24 months
Title
All Revascularization (TLR, TVR, and Non-TVR)
Time Frame
30 Days
Title
All Revascularization (TLR, TVR, and Non-TVR)
Time Frame
6 Months
Title
All Revascularization (TLR, TVR, and Non-TVR)
Time Frame
9 Months
Title
All Revascularization (TLR, TVR, and Non-TVR)
Time Frame
12 months
Title
All Revascularization (TLR, TVR, and Non-TVR)
Description
One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).
Time Frame
24 months
Title
All Death
Description
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame
30 days
Title
All Death
Description
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame
6 months
Title
All Death
Description
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame
9 months
Title
All Death
Description
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame
12 months
Title
All Death
Description
This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame
24 months
Title
All Protocol MI (Including Q-wave or Non-Q-wave)
Description
This is one of the secondary safety endpoint.
Time Frame
30 days
Title
All Protocol MI (Including Q-wave or Non-Q-wave)
Description
This is one of the secondary safety endpoint.
Time Frame
6 months
Title
All Protocol MI (Including Q-wave or Non-Q-wave)
Description
This is one of the secondary safety endpoint.
Time Frame
9 months
Title
All Protocol MI (Including Q-wave or Non-Q-wave)
Description
This is one of the secondary safety endpoint.
Time Frame
12 months
Title
All Protocol MI (Including Q-wave or Non-Q-wave)
Description
This is one of the secondary safety endpoint.
Time Frame
24 months
Title
Target Vessel Protocol MI (TV-MI)
Description
This is one of the secondary safety endpoint.
Time Frame
30 days
Title
Target Vessel Protocol MI (TV-MI)
Description
This is one of the secondary safety endpoint.
Time Frame
6 months
Title
Target Vessel Protocol MI (TV-MI)
Description
This is one of the secondary safety endpoint.
Time Frame
9 months
Title
Target Vessel Protocol MI (TV-MI)
Description
This is one of the secondary safety endpoint.
Time Frame
12 months
Title
Target Vessel Protocol MI (TV-MI)
Description
This is one of the secondary safety endpoint.
Time Frame
24 months
Title
Major Bleeding Complications
Description
Secondary safety endpoint.
Time Frame
30 days
Title
Major Bleeding Complications
Description
Secondary safety endpoint.
Time Frame
6 months
Title
Major Bleeding Complications
Description
Secondary safety endpoint.
Time Frame
9 months
Title
Major Bleeding Complications
Description
Secondary safety endpoint.
Time Frame
12 months
Title
Major Bleeding Complications
Description
Secondary safety endpoint.
Time Frame
24 months
Title
Definite / Probable Stent Thrombosis
Description
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame
Acute (<1 day)
Title
Definite / Probable Stent Thrombosis
Description
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame
Subacute (1 - 30 days)
Title
Definite / Probable Stent Thrombosis
Description
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame
Early (0 - 30 days)
Title
Definite / Probable Stent Thrombosis
Description
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame
Late (31 - 365 days)
Title
Definite / Probable Stent Thrombosis
Description
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame
Very late (366 - 772 days)
Title
Definite / Probable Stent Thrombosis
Description
Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame
Overall (0 - 772 days)
Title
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame
30 days
Title
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame
6 months
Title
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame
9 months
Title
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame
12 months
Title
Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame
24 months
Title
Acute Device Success
Description
Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of < 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.
Time Frame
< or = 1 day
Title
Acute Procedure Success
Description
Per-protocol procedure success is defined as the achievement of a final in-stent DS of < 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non-Q-wave), or repeat revascularization of the target lesion during the hospital stay.
Time Frame
< or = 1 day
Title
Procedure Time
Description
This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.
Time Frame
On day 0, during the procedure.
Title
Amount of Contrast Used
Description
Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.
Time Frame
On day 0, during the procedure.
Title
Fluoroscopy Time
Description
This is the procedure related endpoint.
Time Frame
On day 0, during the procedure.
Title
XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire
Description
A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure.
Time Frame
During the procedure
Title
Follow-up Late Loss
Description
This is one of the Secondary Angiographic Endpoint.
Time Frame
≥13 months.
Title
Follow-up In-stent Minimum Lumen Diameter (MLD)
Time Frame
≥13 months
Title
Follow-up In-stent Percent Diameter Stenosis (DS)
Time Frame
≥13 months
Title
Follow-up In-stent Angiographic Binary Restenosis (ABR)
Time Frame
≥13 months
Title
Follow-up In-segment Minimum Lumen Diameter (MLD)
Time Frame
≥13 months
Title
Follow-up In-segment Percent Diameter Stenosis (DS)
Time Frame
≥13 months
Title
Follow-up In-segment Angiographic Binary Restenosis (ABR)
Time Frame
≥13 months
Title
Percent Diameter Stenosis
Time Frame
pre procedure
Title
Percent Diameter Stenosis (%DS)
Time Frame
post procedure on 0 day
Title
Acute Gain
Time Frame
post procedure on 0 day
Other Pre-specified Outcome Measures:
Title
ID-TVF Rate in Patients With Diabetic Disease
Description
ID-TVF rate in All Diabetes patients.
Time Frame
24 months
Title
ID-TVF Rate in Patients Without Diabetic Disease
Description
ID-TVF rate in Non Diabetes
Time Frame
24 months
Title
ID-TVF Rate in Single Lesion Treated Subgroup
Description
ID-TVF rate in Patients with single lesion treated during the index procedure
Time Frame
24 months
Title
ID-TVF Rate in Dual Lesion Treated Subgroup
Description
ID-TVF rate in Patients with dual lesion treated during the index procedure
Time Frame
24 months
Title
ID-TVF Rate in Single Vessel Treated Subgroup
Description
ID-TVF rate in Patients with single vessels treated during the index procedure.
Time Frame
24 months
Title
ID-TVF Rate in Dual Vessel Treated Subgroup
Description
ID-TVF rate in Patients with dual vessel treated during the index procedure.
Time Frame
24 months
Title
The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.
Description
The composite of ST, all death, and all MI rate in All Diabetes patients.
Time Frame
24 months
Title
The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease
Description
The composite of ST, all death, and all MI rate in Non Diabetes
Time Frame
24 months
Title
The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup
Description
The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure
Time Frame
24 months
Title
The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup
Description
The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure
Time Frame
24 months
Title
The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup
Description
The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.
Time Frame
24 months
Title
The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup
Description
The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.
Time Frame
24 months
Title
ID-TLR Rate in Patients With Diabetic Disease.
Description
Ischemia-driven target lesion revascularization rate in All Diabetes patients.
Time Frame
24 months
Title
ID-TLR Rate in Patients Without Diabetic Disease
Description
Ischemia-driven target lesion revascularization rate in Non Diabetes
Time Frame
24 months
Title
ID-TLR Rate in Single Lesion Treated Subgroup
Description
Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure
Time Frame
24 months
Title
ID-TLR Rate in Dual Lesion Treated Subgroup
Description
Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure
Time Frame
24 months
Title
ID-TLR Rate in Single Vessel Treated Subgroup
Description
Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.
Time Frame
24 months
Title
ID-TLR Rate in Dual Vessel Treated Subgroup
Description
Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
General Inclusion Criteria
Patient must be at least 18 years of age
The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee (EC)-approved ICF prior to procedure.
Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.
Patient must not currently be and must agree not to become a participant in any other clinical trial until completion of his/her 2-year follow-up.
Angiographic Inclusion Criteria
Target lesion(s) must be located in a native de novo coronary artery with a visually estimated diameter between ≥ 2.25 and ≤ 4.0 mm.
Target lesion(s) must measure ≤ 28 mm in length by visual estimation.
A maximum of two de novo lesions can be treated, ie,
One lesion in one vessel, OR
One lesion in each of two vessels, OR
Two lesions in one vessel
Exclusion Criteria:
General Exclusion Criteria
Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure
Patients with known renal insufficiency or failure (eg, serum creatinine level of > 2.5 mg/dL, or patient is on dialysis)
Patient had an MI within 72 hours and creatine kinase-myocardial band isoenzyme (CK-MB) has not returned to the normal range at the index procedure
Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure
Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure
Left ventricular ejection fraction (LVEF) of < 30%.
Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year
Patient's current medical condition has a life expectancy of < 2 years
Patient meets contraindications of the IFU
Angiographic Exclusion Criteria
Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
Lesion located in left main coronary artery
Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries)
Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation
Total occluded lesions (TIMI=0)
Restenotic lesions
Thrombus-containing vessel
Extreme angulation (≥ 90º) proximal to or within the lesion
Excessive tortuosity proximal to or within the lesion
Heavy calcification
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao Runlin, MD, FACC
Organizational Affiliation
Fu Wai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fu Wai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.
City
Shanghai
ZIP/Postal Code
200122
Country
China
12. IPD Sharing Statement
Learn more about this trial
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
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