Sirolimus- and Paclitaxel-Eluting Stents for Small Vessels (ISAR-SMART-3)

January 10, 2008 updated by: Deutsches Herzzentrum Muenchen

Randomized Trial of Paclitaxel-Eluting Stent and Sirolimus-Eluting Stent for Restenosis Reduction in Small Coronary Vessels (ISAR-SMART-3)

The purpose of this study is to compare the efficacy of paclitaxel- and sirolimus-eluting stents to prevent re-blockage of small coronary arteries

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although use of bare metal stents has reduced restenosis in coronary vessels with a diameter ≥3 mm when compared to plain balloon angioplasty, most of the dedicated randomized studies have failed to show a beneficial effect of stent over balloon angioplasty in vessels with a small reference diameter. In spite of refinements in stent design and periprocedural therapy, the risk of restenosis after bare metal stenting in this setting remains elevated. Nowadays, percutaneous coronary interventions in small vessels account for 35-67% of interventional procedures performed in patients with coronary artery disease and, when bare metal stents are used, restenosis will be detected in more than 35% of the treated patients and a repeat revascularization procedure will be needed in more than 20% them. Several randomized trials have shown that stents eluting antiproliferative drugs, with sirolimus- and paclitaxel-eluting stents the only devices approved for commercial use so far, are highly effective in reducing restenosis when compared with bare metal stents. Subgroup analysis from these trials have shown that the efficacy of either sirolimus stent or paclitaxel stent extends also to those patients who undergo coronary stenting in small sized vessels. In addition, three randomized studies of sirolimus-eluting stents and bare metal stents used in coronary arteries smaller than 3 mm have reported 82-96% reduction in the relative risk of restenosis with the sirolimus stents thus, providing convincing evidence on the role of drug-eluting stents as an effective treatment strategy for coronary arteries with a small reference diameter.

At present, there is no direct evidence on the relative efficacy in the prevention of restenosis of sirolimus stent and paclitaxel stent after implantation in small coronary vessels. Selecting the most effective device for this particularly high-risk category that accounts for a large proportion of percutaneous coronary interventions, may have important clinical and economic implications. Comparisons of data from subgroup analysis of different trials have suggested that there might be differences in the efficacy to prevent restenosis between sirolimus and paclitaxel stents. However, indirect comparisons are subject to many limitations and consequently, conclusions based on their results may be erroneous. Therefore, reliable guidance on the selection of the most effective drug-eluting stent for treatment of lesions in coronary vessels with a small reference diameter could be provided only from a head-to-head comparison between these devices.

Comparison:

Sirolimus-eluting stent and paclitaxel-eluting stent in patients undergoing stenting in small coronary vessels.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • Munich, Germany, 80636
        • Deutsches Herzzentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable or unstable angina pectoris and/or a positive stress test
  • "de novo" lesion in small coronary arteries (vessel size <2.8 mm by visual estimation)
  • Written informed consent

Exclusion Criteria:

  • Diabetes mellitus
  • Myocardial infarction within 48 h. before enrollment
  • Target lesion located in the left main trunk or bypass graft
  • Contraindication or known allergy to aspirin, thienopyridines, rapamycin, paclitaxel or stainless steel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
randomized patients get sirolimus stent
Device: Sirolimus-eluting stent (Cypher)
patients have been implanted a Cypher stent
Other Names:
  • Cypher
EXPERIMENTAL: 2
randomized patients get paclitaxel stent
Device: Paclitaxel-eluting stent (Taxus)
patients have been implanted a Taxus stent
Other Names:
  • Taxus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late luminal loss
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Binary angiographic restenosis
Time Frame: 1 year
1 year
Target lesion revascularization
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (ACTUAL)

February 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (ESTIMATE)

September 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2008

Last Update Submitted That Met QC Criteria

January 10, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. S01703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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