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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
Salzburger Landeskliniken
Salzburg, Austria
In-stent Late Loss (LL)
In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up
Time frame: 270 days
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.
Time frame: immediately post-procedure
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.
Time frame: immediately post-procedure
In-segment Late Loss
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up
Time frame: 270 days
Proximal Late Loss
Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up
Time frame: 270 day
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Enrollment
324
C.H.U. - Hopital Michallon
Grenoble, France
CHU Lille - Hôpital Cardiologique
Lille, France
Herzzentrum
Bernau, Germany
Universitätsklinikum
Heidelberg, Germany
Lukas Krankenhaus Neuss
Neuss, Germany
Herzzentrum Siegburg GmbH
Siegburg, Germany
Sheba Medical Center
Ramat Gan, Israel
Azienda Ospedaliera Riuniti
Bergamo, Italy
Ospedale Civile
Mirano, Italy
...and 18 more locations
Distal Late Loss
Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up
Time frame: 270 days
In-stent Angiographic Binary Restenosis Rate
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
Time frame: 270 days
In-segment Angiographic Binary Restenosis Rate
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
Time frame: 270 days
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.
Time frame: 270 days
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.
Time frame: 270 days
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.
Time frame: 0 to 37 days
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.
Time frame: 254 days
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.
Time frame: 365 days
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.
Time frame: 37 days
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.
Time frame: 254 days
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.
Time frame: 393 days
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.
Time frame: 37 days
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.
Time frame: 254 days
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.
Time frame: 393 days
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.
Time frame: 37 days
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.
Time frame: 254 days
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.
Time frame: 393 days
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
Time frame: 37 days
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
Time frame: 254 days
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
Time frame: 393 days