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

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ClinicalTrials.gov Identifier: NCT00598715
Recruitment Status : Completed
First Posted : January 22, 2008
Last Update Posted : December 17, 2010
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: Sirolimus eluting stent Device: Paclitaxel-eluting stent Phase 4

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  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents
Study Start Date : October 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. Late luminal loss at follow-up angiography [ Time Frame: 6-8 months ]

Secondary Outcome Measures :
  1. Need of target lesion revascularization. [ Time Frame: 12 months ]
  2. Combined incidence of death or myocardial infarction. [ Time Frame: 12 months ]
  3. Incidence of stent thrombosis. [ Time Frame: 12 months ]
  4. Incidence of binary restenosis at follow-up angiography [ Time Frame: 6-8 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): 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

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Albert Schomig, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00598715     History of Changes
Other Study ID Numbers: GE IDE No. S02407
First Posted: January 22, 2008    Key Record Dates
Last Update Posted: December 17, 2010
Last Verified: September 2009

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
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Sirolimus
Everolimus
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