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

January 10, 2008
December 16, 2010
October 2007
August 2009   (final data collection date for primary outcome measure)
Late luminal loss at follow-up angiography [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
Late luminal loss at follow-up angiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00598715 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Need of target lesion revascularization. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Combined incidence of death or myocardial infarction. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of stent thrombosis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents
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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Sirolimus eluting stent
    Sirolimus-eluting stent will be implanted
    Other Name: Cypher
  • Device: Paclitaxel-eluting stent
    Paclitaxel-eluting stent will be implanted
    Other Name: Taxus
  • Experimental: Same drug
    sirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent
    Intervention: Device: Sirolimus eluting stent
  • Active Comparator: Different drug
    paclitaxel eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent
    Intervention: Device: Paclitaxel-eluting stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00598715
GE IDE No. S02407
Yes
Albert Schomig, Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Not Provided
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Study Director: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP