Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258596
Status:
COMPLETED
Last Update Posted:
2007-03-06
First Post:
2005-11-23
Brief Title:
Sirolimus-Eluting Stents for Chronic Total Coronary Occlusions
Sponsor:
RD Cardiologie
Organization:
RD Cardiologie
Study Overview
Official Title:
Sirolimus-Eluting Stents for Chronic Total Coronary Occlusions A Randomized Comparison of Bare Metal Stent Implantation With Sirolimus-Eluting Stent Implantation for the Treatment of Chronic Total Coronary Occlusions PRISON II
Status:
COMPLETED
Status Verified Date:
2007-01
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:
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
Detailed Description:
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
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
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