Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis (ISAR-TEST-5)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00598533
First received: January 10, 2008
Last updated: January 3, 2012
Last verified: January 2012

January 10, 2008
January 3, 2012
February 2008
August 2010   (final data collection date for primary outcome measure)
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation [ Time Frame: at one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00598533 on ClinicalTrials.gov Archive Site
  • Late luminal loss [ Time Frame: at 6-8 months follow-up angiography ] [ Designated as safety issue: No ]
  • stent thrombosis [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis
Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis

The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Coronary Heart Disease
  • Device: Rapamycin + Probucol-eluting stent (ISAR stent)
    due to randomization, Rapamycin- + Probucol-eluting stent will be implanted
    Other Name: ISAR stent
  • Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)
    due to randomization, Zotarolimus-eluting stent with polymer will be implanted
    Other Name: Endeavor Resolute
  • Experimental: Dual-DES
    Rapamycin + Probucol-eluting stent
    Intervention: Device: Rapamycin + Probucol-eluting stent (ISAR stent)
  • Active Comparator: ZES
    Polymer based Zotarolimus-eluting stent
    Intervention: Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)
Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, Ibrahim T, Fusaro M, Ott I, Schömig A, Laugwitz KL, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial. Circulation. 2011 Aug 2;124(5):624-32. Epub 2011 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3002
September 2010
August 2010   (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% 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
  • In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

  • Target lesion located in the left main trunk.
  • Target lesion located in the bypass graft.
  • In-stent restenosis.
  • Cardiogenic shock.
  • 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.
  • Known allergy to the study medications: Clopidogrel, Rapamycin, Probucol, Zotarolimus, stainless steel or cobalt chrome.
  • Inability to take clopidogrel for at least 6 months.
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully cooperate with the study protocol.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00598533
GE IDE No. S02907
Yes
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Not Provided
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
January 2012

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