Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428454
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2007-01-29
Brief Title:
Sirolimus-eluting vs Zotarolimus-eluting Stents for Chronic Total Coronary Occlusions
Sponsor:
RD Cardiologie
Organization:
RD Cardiologie
Study Overview
Official Title:
A Randomized Comparison of Sirolimus-eluting Stent Implantation With Zotarolimus-eluting Stent Implantation for the Treatment of Chronic Total Coronary Occlusions The PRISON III Trial
Status:
COMPLETED
Status Verified Date:
2015-06
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 coronary 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 In the PRISON II study we demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO In this prospective randomized trial sirolimus-stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of chronic total coronary occlusions A total of 300 patients will be clinically followed up for 1 6 12 months 2 3 4 5 year with angiographic follow-up at 8 months Quantitative coronary analysis will be performed by an independent core laboratory The primary end point is in-segment late luminal loss at 8 month angiographic follow-up
Detailed Description:
Percutaneous coronary intervention PCI of chronic total occlusions CTO was traditionally limited by high restenosis rates Coronary stenting using bare metal stents significantly decreases restenosis in CTO compared to balloon angioplasty alone but restenosis rates still reach 32-55 In 200 patients with CTO randomized in the PRISON I study we demonstrated a restenosis rate of 22 after bare metal stent BMS 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 The drug zotarolimus ABT-578 a sirolimus analogue is designed to inhibit the cellular process that leads to restenosis In the PRISON II study we have randomized 200 patients with CTO to either BMS implantation or sirolimus-eluting stent implantation and we demonstrated a reduction of in-stent binary restenosis from 36 to 7 and in-segment binary restenosis rates from 41 to 11 in favour of the sirolimus eluting stent However no data are available on direct comparison of the clinical efficacy safety and angiographic outcome of particular drug-eluting stents in patients with CTO and there may be differences between various drug-eluting stents The PRISON III study is designed to address this issue and provide information about two different drug-eluting stents It is a prospective randomized single blinded trial comparing the relative safety clinical efficacy and angiographic outcomes of sirolimus and zotarolimus-eluting stents in patients undergoing successful recanalization of CTO
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