Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents (DESIRE-2)

December 16, 2010 updated by: Deutsches Herzzentrum Muenchen

Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents

For lesions which develop restenosis after a drug-eluting stent, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment of in-stent restenosis after implantation of a DES has poorly been studied. Although there are no data, it may be assumed that certain lesions might be resistant to a given drug and in need of a different DES. Thus, for lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug. This prospective, randomized trial will compare the anti-restenotic efficacy of PES or SES in patients with restenosis after initial implantation of a SES

Study Type

Interventional

Enrollment (Actual)

450

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
        • 1. 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 with ischemic symptoms or evidence of myocardial ischemia in the presence of > 50% re- stenosis after prior implantation of Sirolimus eluting stents in native coronary vessels
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
  • In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

  • Cardiogenic shock
  • Acute myocardial infarction within the first 48 hours from symptom onset.
  • Target lesion located in the left main trunk or bypass graft.
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
  • Allergy to antiplatelet therapy, sirolimus, paclitaxel, stainless steel.
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully comply 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Same drug
sirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent
Device: Sirolimus eluting stent
Sirolimus-eluting stent will be implanted
Other Names:
  • Cypher
Active Comparator: Different drug
paclitaxel eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent
Device: Paclitaxel-eluting stent
Paclitaxel-eluting stent will be implanted
Other Names:
  • Taxus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late luminal loss at follow-up angiography
Time Frame: 6-8 months
6-8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Need of target lesion revascularization.
Time Frame: 12 months
12 months
Combined incidence of death or myocardial infarction.
Time Frame: 12 months
12 months
Incidence of stent thrombosis.
Time Frame: 12 months
12 months
Incidence of binary restenosis at follow-up angiography
Time Frame: 6-8 months
6-8 months

Collaborators and Investigators

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

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Study Director: Julinda Mehilli, MD, 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

October 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 21, 2008

First Posted (Estimate)

January 22, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2010

Last Update Submitted That Met QC Criteria

December 16, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. S02407

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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