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

Ischemic Heart Disease Clinical Trial

— SORT-OUTIII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660478
• Other study ID #: 20050194
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2008
• Last updated: August 28, 2013
• Start date: January 2006
• Est. completion date: October 2009

Study information

• Verified date: September 2008
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2342
• Est. completion date: October 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Endeavor
Comparison of two different drug eluting coronary stents
• Cypher Select
Comparison of two different drug eluting coronary stents

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus

Sponsors (5)

Lead Sponsor	Collaborator
Evald Hoej Christiansen	Aalborg Universitetshospital, Odense University Hospital, Rigshospitalet, Denmark, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months.		9 months	Yes