Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492908
Status:
COMPLETED
Last Update Posted:
2014-05-01
First Post:
2007-06-25
Brief Title:
Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
Sponsor:
University of Bern
Organization:
University of Bern
Study Overview
Official Title:
Randomized Clinical Trial Comparing A Titanium-Nitride-Oxide Coated Stent With A Zotarolimus-Eluting Stent in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2014-04
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:
None
Brief Summary:
A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent Helistent Titan2 Hexacath With a Zotarolimus-Eluting Stent EndeavorTm Medtronic for Percutaneous Coronary Intervention
Detailed Description:
Objectives The purpose of this study is to compare the Titanium-Nitride-Oxide Coated Stent Helistent Titan2 Hexacath with a Zotarolimus-Eluting Stent EndeavorTm Medtronic in a non-inferiority trial
Design Prospective multi-center randomized non-inferiority trial to be conducted at 3 Swiss interventional cardiology centers Patients will be randomized in a single-blind fashion 11 randomization to either the Titanium-Nitride-Oxide Coated Stent Helistent Titan2 Hexacath or the Zotarolimus-Eluting Stent EndeavorTm Medtronic
Study Population Patients with symptomatic coronary artery disease including patients with chronic stable angina silent ischemia unstable angina and non-ST elevation myocardial infarction who qualify for percutaneous coronary interventions
Antiplatelet Therapy Aspirin 100 mg qd indefinitely Clopidogrel 75 mg qd for 3 months
Enrollment A total of 300 patients will be enrolled
All patients will undergo repeat angiography at 6-8 months
All patients will be followed for up to 5 years
Design Prospective multi-center randomized non-inferiority trial to be conducted at 3 Swiss interventional cardiology centers Patients will be randomized in a single-blind fashion 11 randomization to either the Titanium-Nitride-Oxide Coated Stent Helistent Titan2 Hexacath or the Zotarolimus-Eluting Stent EndeavorTm Medtronic
Study Population Patients with symptomatic coronary artery disease including patients with chronic stable angina silent ischemia unstable angina and non-ST elevation myocardial infarction who qualify for percutaneous coronary interventions
Antiplatelet Therapy Aspirin 100 mg qd indefinitely Clopidogrel 75 mg qd for 3 months
Enrollment A total of 300 patients will be enrolled
All patients will undergo repeat angiography at 6-8 months
All patients will be followed for up to 5 years
Study Oversight
Has Oversight DMC:
None
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?:
None