Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

Coronary Heart Disease Clinical Trial

— ISAR-TEST-5  

Official title:

Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598533
• Other study ID #: GE IDE No. S02907
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2008
• Last updated: January 3, 2012
• Start date: February 2008
• Est. completion date: September 2010

Study information

• Verified date: January 2012
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3002
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• Rapamycin + Probucol-eluting stent (ISAR stent)
due to randomization, Rapamycin- + Probucol-eluting stent will be implanted
• polymer based Zotarolimus-eluting stent (Endeavor Resolute)
due to randomization, Zotarolimus-eluting stent with polymer will be implanted

Locations

Country	Name	City	State
Germany	Medizinische Klinik, Klinikum rechts der Isar	Muenchen
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation		at one year	No
Secondary	Late luminal loss		at 6-8 months follow-up angiography	No
Secondary	stent thrombosis		at one year	Yes