Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-01-07 @ 10:05 PM
Study NCT ID:
NCT00598533
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2008-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Study Overview
Official Title:
Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISAR-TEST-5
Brief Summary:
The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis
Detailed 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: