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

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ClinicalTrials.gov Identifier: NCT00660478
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : August 29, 2013
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

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

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Device: Endeavor Device: Cypher Select Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2342 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients
Study Start Date : January 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: September 2008

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