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

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00598715
First received: January 10, 2008
Last updated: December 16, 2010
Last verified: September 2009
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Late luminal loss at follow-up angiography [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need of target lesion revascularization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Combined incidence of death or myocardial infarction. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of stent thrombosis. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of binary restenosis at follow-up angiography [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: October 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Taxus

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

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598715

Locations
Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Study Director: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:

Responsible Party: Albert Schomig, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00598715     History of Changes
Other Study ID Numbers: GE IDE No. S02407
Study First Received: January 10, 2008
Last Updated: December 16, 2010
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Deutsches Herzzentrum Muenchen:
In-stent restenosis
In-DES-restenosis
paclitaxel
sirolimus

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

ClinicalTrials.gov processed this record on May 19, 2013