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Sponsors and Collaborators: |
R&D Cardiologie Cordis Corporation |
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Information provided by: | R&D Cardiologie |
ClinicalTrials.gov Identifier: | NCT00258596 |
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.
Condition | Intervention | Phase |
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Coronary Artery Disease Coronary Disease Coronary Stenosis |
Device: sirolimus-eluting stent |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
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) |
Estimated Enrollment: | 200 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | September 2006 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
St Antonius Hospital | |
Nieuwegein, Netherlands, 3435CM | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands, 1090HM |
Principal Investigator: | Maarten J. Suttorp, MD, PhD | St. Antonius Hospital |
Study ID Numbers: | RDC-2002-01-PRISON II |
Study First Received: | November 23, 2005 |
Last Updated: | March 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00258596 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
drug-eluting stent chronic total occlusion sirolimus-eluting stent zotarolimus-eluting stent QCA |
Arterial Occlusive Diseases Sirolimus Heart Diseases Immunologic Factors Clotrimazole Miconazole Myocardial Ischemia Tioconazole Vascular Diseases Constriction, Pathologic |
Ischemia Arteriosclerosis Immunosuppressive Agents Coronary Stenosis Coronary Disease Coronary Occlusion Anti-Bacterial Agents Antifungal Agents Coronary Artery Disease |
Arterial Occlusive Diseases Sirolimus Anti-Infective Agents Heart Diseases Immunologic Factors Antineoplastic Agents Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Arteriosclerosis Antibiotics, Antineoplastic |
Immunosuppressive Agents Coronary Stenosis Pharmacologic Actions Coronary Disease Coronary Occlusion Anti-Bacterial Agents Antifungal Agents Therapeutic Uses Cardiovascular Diseases Coronary Artery Disease |