Back to resultsSPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
Primary Purpose
Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
TAXUS® Liberté™
XIENCE V® EECSS
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Disease focused on measuring drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
Eligibility Criteria
Inclusion Criteria:
- at least 18 years
- able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
- diagnosed with diabetes, as documented by medical history.
- evidence of myocardial ischemia
- acceptable candidate for coronary artery bypass grafting (CABG) surgery
- agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
- artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
- maximum of one, de novo, target lesion per native major epicardial vessel or side branch
- target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
- target lesion ≤ 28 mm in length by visual estimate
- target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1
Exclusion Criteria:
- known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
- current unstable arrhythmias
- Left ventricular ejection fraction < 30%
- received a heart or any other organ transplant or is on a waiting list for any organ transplant
- receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
- receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
- known hypersensitivity or contraindication to specific agents
- elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
- platelet count limits, white blood cell limits or documented or suspected liver disease
- renal insufficiency
- history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Cerebrovascular accident or transient ischemic attack within the past 6 months
- significant GI or urinary bleed within the past 6 months
- history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
Target lesion meets any of the following criteria:
- In-stent restenotic
- aorto-ostial location (within 3 mm)
- left main location
- located within 2 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX)
- located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation)
- lesion involving a side branch ≥ 2.5 mm in diameter
- lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
- located in a major epicardial vessel that has been previously treated with brachytherapy
- located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), < 9 months prior to the index procedure
- total occlusion (TIMI flow 0), prior to wire crossing
- excessive tortuosity proximal to or within the lesion
- extreme angulation (≥ 90%) proximal to or within the lesion
- heavy calcification
The target vessel contains visible thrombus
Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)
Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
Sites / Locations
- Salzburger Landeskliniken
- C.H.U. - Hopital Michallon
- CHU Lille - Hôpital Cardiologique
- Herzzentrum
- Universitätsklinikum
- Lukas Krankenhaus Neuss
- Herzzentrum Siegburg GmbH
- Sheba Medical Center
- Azienda Ospedaliera Riuniti
- Ospedale Civile
- Azienda Ospedaliera di Padova
- IRCCS Policlinico San Matteo
- Azienda Ospedaliera S. Gdi Dio Salerno
- Institute Jantung Negara
- Medisch Centrum Alkmaar
- Maasstad Ziekenhuis
- Medical University of Bydgoszcz
- General De Alicante
- Hospital Belvigte de Barcelona
- Hospital Santa Creu I Sant Pau
- Clinico San Carlos
- Hospital Puerta de Hierro
- La Paz
- Hospital Virgen de la Arrixaca
- Hospital General de Valencia
- King Chulalongkorn Memorial Hospital
- King's College Hospital
- Wessex Cardiac Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TAXUS® Liberté™
XIENCE V® EECSS
Arm Description
Outcomes
Primary Outcome Measures
In-stent Late Loss (LL)
In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up
Secondary Outcome Measures
Clinical Device Success (Per-lesion)
Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.
Clinical Procedure Success (Per-patient)
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.
In-segment Late Loss
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up
Proximal Late Loss
Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up
Distal Late Loss
Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up
In-stent Angiographic Binary Restenosis Rate
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
In-segment Angiographic Binary Restenosis Rate
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
In-stent Percent Diameter Stenosis (% DS)
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.
This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
In-segment Percent Diameter Stenosis (% DS)
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.
This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement.
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement.
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement.
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
TLR 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. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
TLR 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. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
TLR 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. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs.
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs.
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs.
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.
Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.
Target Vessel Revascularization (TVR): Target vessel revascularization 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.
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.
Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.
Target Vessel Revascularization (TVR): Target vessel revascularization 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.
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.
Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.
Target Vessel Revascularization (TVR): Target vessel revascularization 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.
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Any revascularization: TLR or TVR or non-TVR
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Any revascularization: TLR or TVR or non-TVR
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Any revascularization: TLR or TVR or non-TVR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01171820
Brief Title
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
Official Title
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).
Detailed Description
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.
The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Diabetic study after 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Keywords
drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
324 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAXUS® Liberté™
Arm Type
Active Comparator
Arm Title
XIENCE V® EECSS
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TAXUS® Liberté™
Intervention Description
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
Intervention Type
Device
Intervention Name(s)
XIENCE V® EECSS
Intervention Description
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
Primary Outcome Measure Information:
Title
In-stent Late Loss (LL)
Description
In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up
Time Frame
270 days
Secondary Outcome Measure Information:
Title
Clinical Device Success (Per-lesion)
Description
Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.
Time Frame
immediately post-procedure
Title
Clinical Procedure Success (Per-patient)
Description
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.
Time Frame
immediately post-procedure
Title
In-segment Late Loss
Description
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up
Time Frame
270 days
Title
Proximal Late Loss
Description
Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up
Time Frame
270 day
Title
Distal Late Loss
Description
Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up
Time Frame
270 days
Title
In-stent Angiographic Binary Restenosis Rate
Description
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
Time Frame
270 days
Title
In-segment Angiographic Binary Restenosis Rate
Description
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
Time Frame
270 days
Title
In-stent Percent Diameter Stenosis (% DS)
Description
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.
This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame
270 days
Title
In-segment Percent Diameter Stenosis (% DS)
Description
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.
This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame
270 days
Title
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
Description
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement.
Time Frame
0 to 37 days
Title
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
Description
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement.
Time Frame
254 days
Title
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
Description
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement.
Time Frame
365 days
Title
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
Description
TLR 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. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Time Frame
37 days
Title
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
Description
TLR 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. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Time Frame
254 days
Title
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
Description
TLR 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. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Time Frame
393 days
Title
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
Description
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs.
Time Frame
37 days
Title
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
Description
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs.
Time Frame
254 days
Title
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
Description
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs.
Time Frame
393 days
Title
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
Description
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.
Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.
Target Vessel Revascularization (TVR): Target vessel revascularization 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
37 days
Title
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
Description
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.
Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.
Target Vessel Revascularization (TVR): Target vessel revascularization 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
254 days
Title
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
Description
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.
Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.
Target Vessel Revascularization (TVR): Target vessel revascularization 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
393 days
Title
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)
Description
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Any revascularization: TLR or TVR or non-TVR
Time Frame
37 days
Title
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)
Description
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Any revascularization: TLR or TVR or non-TVR
Time Frame
254 days
Title
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)
Description
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.
MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Any revascularization: TLR or TVR or non-TVR
Time Frame
393 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least 18 years
able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
diagnosed with diabetes, as documented by medical history.
evidence of myocardial ischemia
acceptable candidate for coronary artery bypass grafting (CABG) surgery
agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
maximum of one, de novo, target lesion per native major epicardial vessel or side branch
target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
target lesion ≤ 28 mm in length by visual estimate
target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1
Exclusion Criteria:
known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
current unstable arrhythmias
Left ventricular ejection fraction < 30%
received a heart or any other organ transplant or is on a waiting list for any organ transplant
receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
known hypersensitivity or contraindication to specific agents
elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
platelet count limits, white blood cell limits or documented or suspected liver disease
renal insufficiency
history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Cerebrovascular accident or transient ischemic attack within the past 6 months
significant GI or urinary bleed within the past 6 months
history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
Target lesion meets any of the following criteria:
In-stent restenotic
aorto-ostial location (within 3 mm)
left main location
located within 2 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX)
located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation)
lesion involving a side branch ≥ 2.5 mm in diameter
lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
located in a major epicardial vessel that has been previously treated with brachytherapy
located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), < 9 months prior to the index procedure
total occlusion (TIMI flow 0), prior to wire crossing
excessive tortuosity proximal to or within the lesion
extreme angulation (≥ 90%) proximal to or within the lesion
heavy calcification
The target vessel contains visible thrombus
Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)
Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eberhard Grube, MD
Organizational Affiliation
International Heart Center Rhein-Ruhr, Essen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Upendra Kaul, MD
Organizational Affiliation
Fortis Hospital, New Delhi, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salzburger Landeskliniken
City
Salzburg
Country
Austria
Facility Name
C.H.U. - Hopital Michallon
City
Grenoble
Country
France
Facility Name
CHU Lille - Hôpital Cardiologique
City
Lille
Country
France
Facility Name
Herzzentrum
City
Bernau
Country
Germany
Facility Name
Universitätsklinikum
City
Heidelberg
Country
Germany
Facility Name
Lukas Krankenhaus Neuss
City
Neuss
Country
Germany
Facility Name
Herzzentrum Siegburg GmbH
City
Siegburg
Country
Germany
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Azienda Ospedaliera Riuniti
City
Bergamo
Country
Italy
Facility Name
Ospedale Civile
City
Mirano
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Azienda Ospedaliera S. Gdi Dio Salerno
City
Salerno
Country
Italy
Facility Name
Institute Jantung Negara
City
Kuala Lumpur
Country
Malaysia
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
Medical University of Bydgoszcz
City
Bydgoszcz
Country
Poland
Facility Name
General De Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Belvigte de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
Country
Spain
Facility Name
Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital General de Valencia
City
Valencia
Country
Spain
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Facility Name
Wessex Cardiac Unit
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.gov/ct2/show/NCT00402272?term=SPIRIT+V&rank=1
Description
SPIRIT V registry arm
Learn more about this trial
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
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