Ignite Creation Date:
2024-05-05 @ 10:01 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01016041
Status:
COMPLETED
Last Update Posted:
2015-12-28
First Post:
2009-11-16
Brief Title:
A Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice The COMPARE Trial
Sponsor:
Maasstad Hospital
Organization:
Maasstad Hospital
Study Overview
Official Title:
A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice The COMPARE Trial
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPARE 1
Brief Summary:
Instead of treating in-stent restenosis the best strategy for patients is preventing in-stent restenosis Recent advances in the understanding of the cellular mechanism responsible for smooth muscle cell proliferation neointimal hyperplasia together with improvement in stent coating and eluting technology have provided the scientific background to develop drug eluting stents Drug eluting stents DES are now the most promising development in interventional cardiology Different classes of drugs mounted in a polymer layer on the surface of the stent have shown to be very effective in preventing neointimal hyperplasia Currently there are 7 DES stents CE marked and commercially available on the market Two stents respectively the sirolimus eluting Cypher stent and the paclitaxel eluting Taxus stent are in clinical use since 2002 The Cypher stent consists of the Bx sonic stentballoon platform The stent is coated with a non-degradable biocompatible PBMAPEVA polymer which elutes sirolimius The Taxus stent consists of the Express2 balloonstent platform coated with non-degradable biocompatible Translute polymer which elutes paclitaxel
Recent large randomized trials like RAVEL SIRIUS E-SIRIUS C-SIRIUS Cypher versus bare metal BX sonic stent TAXUS II IV V VI Taxus versus bare metal Express stent have shown that DES dramatically reduce the incidence of in-stent restenosis and subsequently the need for target lesion revascularization in patients with non complex and moderate long de-novo coronary lesions in vessels with a diameter between 25 -35 mm1-11 Considering the very encouraging results of these early clinical trials with so far mid long term follow-up there is the need to explore the utilization of DES in the other subsets of coronary lesions like long lesions chronic total occlusions venous graft lesions thrombotic lesions restenosis lesions ostial and bifurcation lesions and lesions in large vessels
As the result from the previous reported randomized trials FDA and other regulatory institutes require that new DES are now being evaluated against one of the former DES Cypher or Taxus The XIENCE-V stent is a second generation DES with thinner and more flexible Cobalt-Chromium stent struts compared to the first generation Stainless Steel stent struts of Cypher and Taxus This study addresses the questions whether the XIENCE-V stent has superior clinical results as the Taxus stent in the general population that is being referred for percutaneous coronary intervention PCI
Objective of the study
The main objective of the study is a head tot head comparison of the everolimus coated XIENCE-V stent with the paclitaxel coated TAXUS stent in order to observe whether there is a difference in clinical outcome between both stents
Efficacy of both stents will be assessed by the composite end point of all death non fatal myocardial infarction and target vessel revascularization
Study design
Single center randomised open label study in all-comers referred for PCI
Study population
Approximately 1600 consecutive patients with coronary artery disease who are eligible according to the in- and exclusion criteria will be enrolled and randomized on a 11 basis
Primary study parametersoutcome of the study
The primary end point of the study is the composite end point of all death non fatal myocardial infarction target vessel revascularization at 1 year
Secondary study parametersoutcome of the study
The secondary end points of the study are
A The combined endpoint of cardiac death non fatal myocardial infarction ischemic driven target lesion revascularization TLR rate at 1 6 and 12 months follow-up
B The combined endpoint of all death non fatal myocardial infarction target vessel revascularization TVR rate at 2 3 4 and 5 years
Nature and extent of the burden and risks associated with participation benefit and group relatedness
The burden for the patient consists of filling in 8 questionnaires 1 A4 per questionnaire in 5 years time
The first 3 questionnaires in the first year are also requested for monitoring purposes by the Ministry of Health and the Dutch Cardiology Society Nederlandse Vereniging Voor Cardiologie NVVC
There is no risk for the patient related to participation in this study The patient will receive a Taxus or Xience-V stent anyhow if the indication for a DES stent exists
Recent large randomized trials like RAVEL SIRIUS E-SIRIUS C-SIRIUS Cypher versus bare metal BX sonic stent TAXUS II IV V VI Taxus versus bare metal Express stent have shown that DES dramatically reduce the incidence of in-stent restenosis and subsequently the need for target lesion revascularization in patients with non complex and moderate long de-novo coronary lesions in vessels with a diameter between 25 -35 mm1-11 Considering the very encouraging results of these early clinical trials with so far mid long term follow-up there is the need to explore the utilization of DES in the other subsets of coronary lesions like long lesions chronic total occlusions venous graft lesions thrombotic lesions restenosis lesions ostial and bifurcation lesions and lesions in large vessels
As the result from the previous reported randomized trials FDA and other regulatory institutes require that new DES are now being evaluated against one of the former DES Cypher or Taxus The XIENCE-V stent is a second generation DES with thinner and more flexible Cobalt-Chromium stent struts compared to the first generation Stainless Steel stent struts of Cypher and Taxus This study addresses the questions whether the XIENCE-V stent has superior clinical results as the Taxus stent in the general population that is being referred for percutaneous coronary intervention PCI
Objective of the study
The main objective of the study is a head tot head comparison of the everolimus coated XIENCE-V stent with the paclitaxel coated TAXUS stent in order to observe whether there is a difference in clinical outcome between both stents
Efficacy of both stents will be assessed by the composite end point of all death non fatal myocardial infarction and target vessel revascularization
Study design
Single center randomised open label study in all-comers referred for PCI
Study population
Approximately 1600 consecutive patients with coronary artery disease who are eligible according to the in- and exclusion criteria will be enrolled and randomized on a 11 basis
Primary study parametersoutcome of the study
The primary end point of the study is the composite end point of all death non fatal myocardial infarction target vessel revascularization at 1 year
Secondary study parametersoutcome of the study
The secondary end points of the study are
A The combined endpoint of cardiac death non fatal myocardial infarction ischemic driven target lesion revascularization TLR rate at 1 6 and 12 months follow-up
B The combined endpoint of all death non fatal myocardial infarction target vessel revascularization TVR rate at 2 3 4 and 5 years
Nature and extent of the burden and risks associated with participation benefit and group relatedness
The burden for the patient consists of filling in 8 questionnaires 1 A4 per questionnaire in 5 years time
The first 3 questionnaires in the first year are also requested for monitoring purposes by the Ministry of Health and the Dutch Cardiology Society Nederlandse Vereniging Voor Cardiologie NVVC
There is no risk for the patient related to participation in this study The patient will receive a Taxus or Xience-V stent anyhow if the indication for a DES stent exists
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None