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

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ClinicalTrials.gov Identifier: NCT00146575
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : January 11, 2008
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Study Description
Brief Summary:
The purpose of this study is to compare the efficacy of paclitaxel- and sirolimus-eluting stents to prevent re-blockage of small coronary arteries

Condition or disease Intervention/treatment Phase
Coronary Disease Device: Sirolimus-eluting stent (Cypher) Device: Paclitaxel-eluting stent (Taxus) Phase 4

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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Paclitaxel-Eluting Stent and Sirolimus-Eluting Stent for Restenosis Reduction in Small Coronary Vessels (ISAR-SMART-3)
Study Start Date : June 2003
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
randomized patients get sirolimus stent
Device: Sirolimus-eluting stent (Cypher)
patients have been implanted a Cypher stent
Other Name: Cypher
Experimental: 2
randomized patients get paclitaxel stent
Device: Paclitaxel-eluting stent (Taxus)
patients have been implanted a Taxus stent
Other Name: Taxus

Outcome Measures

Primary Outcome Measures :
  1. Late luminal loss [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Binary angiographic restenosis [ Time Frame: 1 year ]
  2. Target lesion revascularization [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146575

Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Deutsches Herzzentrum
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Study Chair: Albert Schomig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
More Information

ClinicalTrials.gov Identifier: NCT00146575     History of Changes
Other Study ID Numbers: GE IDE No. S01703
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
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