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

This study has been completed.
Sponsor:
Collaborators:
Aalborg Universitetshospital
Odense University Hospital
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00660478
First received: April 9, 2008
Last updated: August 28, 2013
Last verified: September 2008
  Purpose

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


Condition Intervention Phase
Ischemic Heart Disease
Device: Endeavor
Device: Cypher Select
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • 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. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 2342
Study Start Date: January 2006
Study Completion Date: October 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Zotarolimus eluting stent
Device: Endeavor
Comparison of two different drug eluting coronary stents
Other Name: 1. Endeavor
Active Comparator: 2
Sirolimus stent
Device: Cypher Select
Comparison of two different drug eluting coronary stents
Other Name: 1. Cypher

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660478

Locations
Denmark
Aarhus University Hospital, Skejby
Aarhus, Denmark, DK-8200
Sponsors and Collaborators
Evald Hoej Christiansen
Aalborg Universitetshospital
Odense University Hospital
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Investigators
Study Chair: Jens F Lassen, MD, PhD Aarhus University Hospital Skejby
Principal Investigator: Klaus Rasmussen, MD, DMSc Aalborg Universitetshospital
  More Information

No publications provided by Aarhus University Hospital Skejby

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Evald Hoej Christiansen, MD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT00660478     History of Changes
Other Study ID Numbers: 20050194
Study First Received: April 9, 2008
Last Updated: August 28, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Coronary Disease
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014