A Phase 3 interventional study of sirolimus-eluting stent in Coronary Artery Disease, Coronary Disease and Coronary Stenosis, sponsored by R&D Cardiologie. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-03-06.
Sponsored by R&D Cardiologie · Phase 3, Interventional, and Treatment
Primary intracoronary stent placement after successfully crossing chronic total occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. Whether sirolimus-eluting stents are superior to bare metal stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation will be compared with sirolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 200 patients will be followed up for 6, 12, and 24 months with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is the binary angiographic restenosis and reocclusion rate at 6 month follow-up.
Since data from the 2 landmark studies, the BENESTENT and STRESS studies, showed that coronary stenting significantly decreases restenosis as compared with conventional balloon angioplasty, this treatment modality has shown to be superior in an increasing number of indications. Percutaneous coronary intervention of chronic total occlusions (CTO), however, is still limited by high restenosis rates. Although coronary stenting using bare metal stents significantly decreases restenosis in CTO, restenosis rates still reach 32% to 55%.
In 200 patients with CTO randomized in the PRISON I study, we demonstrated a restenosis rate of 22% after bare metal stent implantation as compared with 33% after conventional balloon angioplasty. During the past few years, sirolimus (rapamycin), a cytostatic macrocyclic lactone with anti-inflammatory and antiproliferative properties, delivered from a polymer-encapsulated stent was shown to almost eliminate the risk of restenosis in selected groups of patients.
In this prospective, randomized, single-blind trial we enrolled 200 patients with chronic total occlusions: 100 were randomly assigned to receive bare metal BxVelocity™ stents, and 100 to receive sirolimus-eluting Cypher™ stents. The primary endpoint was angiographic binary restenosis rate at six months follow-up. Secondary endpoints were a composite of major adverse cardiac events, target vessel failure, in-stent and in-segment minimal lumen diameter, percentage diameter stenosis, and late luminal loss at six months follow-up. Clinical long-term follow-up will performed up till 24 months
5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 200 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →R&D Cardiologie is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The binary restenosis rate (defined as restenosis >50% on follow-up angiography) at six-month angiography
A composite of: Major adverse cardiac events (death, myocardial infarction, and ischemia driven target lesion revascularization)
Target vessel failure (defined as a composite of death from cardiac causes, myocardial infarction, and ischemia-driven target-vessel revascularization) at 6 month
In-stent and in-segment minimal lumen diameter
Percentage in-stent and in-segment diameter stenosis
In-stent and in-segment late luminal loss at six months follow-up
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R&D Cardiologie