Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization

This study has been completed.
Sponsor:
Collaborator:
University of Zurich
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00297661
First received: February 22, 2006
Last updated: October 19, 2006
Last verified: February 2006
  Purpose

Context: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents.

Objective: To determine differences in safety and efficacy between sirolimus and paclitaxel eluting stents.


Condition Intervention Phase
Coronary Heart Disease
Device: Sirolimus-eluting stent
Device: Paclitaxel-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization: SIRTAX Trial

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • Major adverse cardiac events at nine months (composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization)

Secondary Outcome Measures:
  • Clinical: Ischemia-driven target lesion revascularization, target-vessel revascularization, and target-vessel failure (composite of cardiac death, myocardial infarction or ischemia-driven target-vessel revascularization)
  • Angiographic: In-segment late luminal loss

Estimated Enrollment: 1012
Study Start Date: April 2003
Detailed Description:

Design: Randomized controlled, observer-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents

Patients: 1012 patients undergoing percutaneous coronary intervention. The two groups had similar baseline clinical and angiographic characteristics.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with either stable angina or an acute coronary syndrome were eligible to participate if they had at least one lesion with stenosis of at least 50 percent in a vessel with a reference diameter between 2.25 and 4.00 mm that was suitable for stent implantation.

Exclusion Criteria:

Allergy to antiplatelet drugs, heparin, stainless steel, contrast agents, sirolimus, or paclitaxel; participation in another coronary-device study; and terminal illness.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00297661

Locations
Switzerland
University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
University of Zurich
Investigators
Principal Investigator: Stephan Windecker, MD Department of Cardiology, University Hospital Bern
Study Director: Peter Juni, MD Department of Social and Preventive Medicine, University of Bern
Study Chair: Bernhard Meier, MD Department of Cardiology, University Hospital Bern
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00297661     History of Changes
Other Study ID Numbers: KEK-33/2003
Study First Received: February 22, 2006
Last Updated: October 19, 2006
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Bern:
Coronary Revascularization
Sirolimus-eluting stents
Paclitaxel-eluting stents

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Sirolimus
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014