The Efficacy of Three Different Limus Agent-Eluting Stents to Prevent Restenosis (ISAR-TEST-2)

June 16, 2008 updated by: Deutsches Herzzentrum Muenchen

Randomized Comparison of 3 Limus Agent-Eluting Stents for the Reduction of Coronary Restenosis

The purpose of this study is to evaluate the efficacy of 3 different drug-eluting-stent platforms to reduce coronary artery reblockage after stent implantation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (DES). DESs working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neontimal proliferation, the main cause of lumen re-narrowing after stent implantation.At present, several DES platforms have been developed and evaluated for clinical use. They differ between them with regard to the stent type, anti-proliferative drug, presence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. Most of the DES platforms have used agents from the "limus family". Although the majority of DESs employ polymer coating to control drug storage and release, in view of the increasing safety and efficacy associated with the long-term presence of polymers a strong interest has recently been shown in the development DES platforms that do not require permanent polymers. Trials as ACTION or JUPITER II have demonstrated that not all DESs are associated with the expected improved outcomes. On the other hand, not all successful DESs have been equally effective in the reduction of restenosis. Thus, rapamycin-eluting stents (Cypher stents) have been associated with lower angiographic and clinical restenosis rates than paclitaxel-eluting stents (Taxus stents). Similarly, Cypher stents have been superior to Endeavor stents regarding the primary end point of late luminal loss in the recent ENDEAVOR III trial. Meanwhile, the on-site rapamycin-coated stents (ISAR stents) had an equivalent antiproliferative efficacy to Taxus stents in the ISAR-TEST trial. However, none of these studies evaluated angiographic restenosis as their primary endpoint and no direct comparisons between the 3 DES -Cypher, Endeavor and ISAR stents, have been performed. The Cypher stent is a stainless steel stent coated with sirolimus with use of permanent polymers while the Endeavor stent is a cobalt alloy based stent coated with zotarolimus which also uses permanent polymers for drug-storage and release. The ISAR stent is a rough surface stainless steel stent that can be coated with sirolimus in the cath lab without requiring permanent polymeric coating.

Study Type

Interventional

Enrollment (Actual)

1007

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, 81675
        • First Medizinische Klinik, Klinikum rechts der Isar

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:

Patients older than age 18 ´ presence of ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

Target lesion located in the left main trunk or bypass graft In-stent restenosis Cardiogenic shock Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance Known allergy to the study medications: aspirin, clopidogrel, zotarolimus, sirolimus, stainless steel, or cobalt alloy Pregnancy (present, suspected or planned) or positive pregnancy test Previous enrollment in this trial Patient's inability to fully cooperate with the study protocol

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Rapamycin-eluting Stent (Cypher)
Device: Rapamycin-eluting Stent
due to randomization, Cypher stent will be implanted
Other Names:
  • Cypher
Device: Rapamycin-eluting Stent
due to randomization, rapamycin-eluting stent will be implanted
Active Comparator: B
Zotarolimus-eluting Stent (Endeavor)
Device: Zotarolimus-eluting Stent
due to randomization, Endeavor stent will be implanted
Other Names:
  • Endeavor
Active Comparator: C
Rapamycin-eluting Stent
Device: Rapamycin-eluting Stent
due to randomization, Cypher stent will be implanted
Other Names:
  • Cypher
Device: Rapamycin-eluting Stent
due to randomization, rapamycin-eluting stent will be implanted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary end point of the study is the incidence of binary angiographic restenosis at 6-8 month follow-up angiography, measured by QCA in the in-segment area.
Time Frame: 6-8 months
6-8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The need of target lesion revascularization defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia.
Time Frame: 9-12 months
9-12 months
The combined incidence of death or myocardial infarction.
Time Frame: 9-12 months
9-12 months
In-stent late luminal loss.
Time Frame: 9-12 months
9-12 months
Incidence of stent thrombosis.
Time Frame: 9-12 months
9-12 months

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

March 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

May 31, 2006

First Submitted That Met QC Criteria

May 31, 2006

First Posted (Estimate)

June 1, 2006

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 16, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. S02206

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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