Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247208
Status:
COMPLETED
Last Update Posted:
2012-04-26
First Post:
2005-10-31
Brief Title:
The SOS Stenting Of Saphenous Vein Grafts Trial
Sponsor:
North Texas Veterans Healthcare System
Organization:
North Texas Veterans Healthcare System
Study Overview
Official Title:
The SOS Stenting Of Saphenous Vein Grafts Randomized-controlled Trial of a Paclitaxel-eluting Stent vs a Bare Metal Stent in Saphenous Vein Graft Lesions
Status:
COMPLETED
Status Verified Date:
2012-04
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:
None
Brief Summary:
The main purpose of this study is to determine whether implantation of a paclitaxel-eluting stent Taxus in saphenous vein graft lesions will reduce the incidence of in-stent restenosis after 12 months when compared to a similar bare metal stent
Detailed Description:
Introduction The prevalence of coronary artery bypass graft CABG surgery is high in the veteran population Saphenous veins are used as conduits in the majority of CABG operations Compared to arterial conduits saphenous vein grafts SVGs have a high rate of failure requiring percutaneous coronary intervention PCI or repeat CABG Bare metal stents are currently used in the majority of PCI in SVGs because they increase the procedural success rate and decrease restenosis However even with the use of bare metal stents restenosis still occurs in 37-53 of the SVGs often requiring repeat target vein graft revascularization
Drug-eluting stents DES have been a major breakthrough in percutaneous coronary intervention because they significantly reduce the incidence of in-stent restenosis in de novo lesions of native coronary arteries Even though no randomized controlled trials have compared DES with bare stents in SVG interventions DES are increasingly being used off label in this setting based on registry data DES are expensive and may not provide benefit in SVGs since the atherosclerotic process is different in SVGs and in native coronary arteries We propose to compare the 12-month angiographic restenosis rates after implantation of a polymer-based paclitaxel-eluting stent or the Express-2 bare metal stent which is identical to the paclitaxel-eluting stent but has no drug coating in saphenous vein graft lesions
Hypothesis Compared to implantation of a bare metal stent implantation of a similar paclitaxel-eluting stent Taxus Boston Scientific Nattick Massachusetts in saphenous vein graft lesion will reduce the incidence of angiographic in-stent restenosis after 12 months
Specific objectives We propose to randomize patients undergoing stenting of a saphenous vein graft lesion to a bare metal stent or an identical paclitaxel-eluting stent Taxus in order to determine
1 whether the paclitaxel-eluting stent will reduce the incidence of binary angiographic in-stent restenosis as assessed by 12-month follow-up quantitative coronary angiography primary study endpoint and
2 whether the paclitaxel-eluting stent will reduce the 24-month incidence of ischemia-driven target vessel revascularization target vessel failure overall major adverse cardiac and cerebrovascular events and intra-stent intimal hyperplasia accumulation as measured by intravascular ultrasound secondary endpoints
Drug-eluting stents DES have been a major breakthrough in percutaneous coronary intervention because they significantly reduce the incidence of in-stent restenosis in de novo lesions of native coronary arteries Even though no randomized controlled trials have compared DES with bare stents in SVG interventions DES are increasingly being used off label in this setting based on registry data DES are expensive and may not provide benefit in SVGs since the atherosclerotic process is different in SVGs and in native coronary arteries We propose to compare the 12-month angiographic restenosis rates after implantation of a polymer-based paclitaxel-eluting stent or the Express-2 bare metal stent which is identical to the paclitaxel-eluting stent but has no drug coating in saphenous vein graft lesions
Hypothesis Compared to implantation of a bare metal stent implantation of a similar paclitaxel-eluting stent Taxus Boston Scientific Nattick Massachusetts in saphenous vein graft lesion will reduce the incidence of angiographic in-stent restenosis after 12 months
Specific objectives We propose to randomize patients undergoing stenting of a saphenous vein graft lesion to a bare metal stent or an identical paclitaxel-eluting stent Taxus in order to determine
1 whether the paclitaxel-eluting stent will reduce the incidence of binary angiographic in-stent restenosis as assessed by 12-month follow-up quantitative coronary angiography primary study endpoint and
2 whether the paclitaxel-eluting stent will reduce the 24-month incidence of ischemia-driven target vessel revascularization target vessel failure overall major adverse cardiac and cerebrovascular events and intra-stent intimal hyperplasia accumulation as measured by intravascular ultrasound secondary endpoints
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