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 Universityhospital

Odense University Hospital

University Hospital, Gentofte, Copenhagen

Rigshospitalet, Denmark

Information provided by:

Skejby Hospital

ClinicalTrials.gov Identifier:

NCT00660478

First received: April 9, 2008

Last updated: November 15, 2010

Last verified: September 2008

History of Changes

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:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Further study details as provided by Skejby Hospital:

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

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

Locations

Denmark
Aarhus University Hospital, Skejby
Aarhus, Denmark, DK-8200

Sponsors and Collaborators

Skejby Hospital

Aalborg Universityhospital

Odense University Hospital

University Hospital, Gentofte, Copenhagen

Rigshospitalet, Denmark

Investigators

Study Chair:	Jens F Lassen, MD, PhD	Skejby Hospital
Principal Investigator:	Klaus Rasmussen, MD, DMSc	Aalborg Universityhospital

More Information

No publications provided by Skejby Hospital

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

Maeng M, Tilsted HH, Jensen LO, Kaltoft A, Kelbæk H, Abildgaard U, Villadsen AB, Krusell LR, Ravkilde J, Hansen KN, Christiansen EH, Aarøe J, Jensen JS, Kristensen SD, Bøtker HE, Madsen M, Thayssen P, Sørensen HT, Thuesen L, Lassen JF. 3-Year clinical outcomes in the randomized SORT OUT III superiority trial comparing zotarolimus- and sirolimus-eluting coronary stents. JACC Cardiovasc Interv. 2012 Aug;5(8):812-8. doi: 10.1016/j.jcin.2012.04.008.

Jensen LO, Maeng M, Thayssen P, Villadsen A, Krusell L, Botker HE, Pedersen KE, Aaroe J, Christiansen EH, Vesterlund T, Hansen KN, Ravkilde J, Tilsted HH, Lassen JF, Thuesen L. Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial. EuroIntervention. 2011 Jul;7(3):323-31.

Rasmussen K, Maeng M, Kaltoft A, Thayssen P, Kelbaek H, Tilsted HH, Abildgaard U, Christiansen EH, Engstrøm T, Krusell LR, Ravkilde J, Hansen PR, Hansen KN, Abildstrøm SZ, Aarøe J, Jensen JS, Kristensen SD, Bøtker HE, Madsen M, Johnsen SP, Jensen LO, Sørensen HT, Thuesen L, Lassen JF; SORT OUT III study group. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial. Lancet. 2010 Mar 27;375(9720):1090-9. Epub 2010 Mar 16.

Responsible Party:	Jens Flensted Lassen, associate professor, MD, PhD, FESC, Aarhus University Hospital, Skejby
ClinicalTrials.gov Identifier:	NCT00660478 History of Changes
Other Study ID Numbers:	20050194
Study First Received:	April 9, 2008
Last Updated:	November 15, 2010
Health Authority:	Denmark: Ethics Committee Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:

Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

Chest Pain
Pain
Signs and Symptoms
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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