Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients

Phase 3

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Device: Endeavor; Device: Cypher Select

• Registration Number: NCT00660478
• Lead Sponsor: Evald Hoej Christiansen

Brief Summary

Randomized clinical comparison of the serolimus eluting Cypher stent and the zotarolimus eluting Endeavor stent.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-12
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-17
• Status Verified: 2008-09
• Study Completion: 2009-10
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2342

Inclusion Criteria

• All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centers in Denmark can be included in the study.

Exclusion Criteria

• The patient will not participate
• The patient participates in other randomized stent studies
• Expected survival < 1 year
• Allergy to Aspirin, Clopidogrel or Ticlopidine
• Allergy to Sirolimus or ABT-578

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Endeavor	Zotarolimus eluting stent
2	Cypher Select	Sirolimus stent

Primary Outcome Measures

Name	Time	Method
In a randomized study to compare the Endeavor and the Cypher Select coronary stents by assessing MACE (cardiac death, myocardial infarction, stent thrombosis and target vessel revascularization) after 9 months.	9 months

Secondary Outcome Measures

Name	Time	Method
To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months.	9 months

Trial Locations

Locations (1)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark