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

German Heart Center Munich

Status and phase

Completed

Phase 4

Conditions

Coronary Heart Disease

Treatments

Device: Rapamycin + Probucol-eluting stent (ISAR stent)

Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)

Study type

Interventional

Funder types

Other

Identifiers

NCT00598533

GE IDE No. S02907

Details and patient eligibility

About

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

Full 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.

Enrollment

3,002 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.