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NCT Number: NCT00258596

Sirolimus-Eluting Stents for Chronic Total Coronary Occlusions

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Estimated duration of the chronic total coronary occlusion of at least two weeks
  • Evidence of ischemia related to the target vessel (signs of ischemia during an abnormal exercise test, defined as ST depression of at least 1.0 mm that is horizontal or down-sloping or up-sloping ST depression of at least 2.0 mm or signs of ischemia found during nuclear imaging with exercise, dobutamine or adenosine).

Exclusion criteria

  • The lesion could not be crossed
  • The use of heparin, aspirin and clopidogrel was prohibited
  • Severe renal failure (creatinine>250µmol/L)
  • Patients were unwilling or unable to complete follow-up.

Treatment and study plan

Sirolimus-eluting stent

Device

Primary outcomes

  1. The binary restenosis rate (defined as restenosis >50% on follow-up angiography) at six-month angiography

Secondary outcomes

  1. A composite of: Major adverse cardiac events (death, myocardial infarction, and ischemia driven target lesion revascularization)

  2. Target vessel failure (defined as a composite of death from cardiac causes, myocardial infarction, and ischemia-driven target-vessel revascularization) at 6 month

  3. In-stent and in-segment minimal lumen diameter

  4. Percentage in-stent and in-segment diameter stenosis

  5. In-stent and in-segment late luminal loss at six months follow-up

Sponsors and collaborators

Lead sponsor

R&D Cardiologie

Other

Collaborators

  • Cordis US Corp.

Registry information

Official study 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)

Important dates

Study start
2003
Study completion
2006
First posted
Nov 24, 2005
Registry last updated
Mar 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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