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

Primary Purpose

Ischemic Heart Disease

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Endeavor
Cypher Select
Sponsored by
Evald Hoej Christiansen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Zotarolimus eluting stent

Sirolimus stent

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2008
Last Updated
August 28, 2013
Sponsor
Evald Hoej Christiansen
Collaborators
Aalborg University Hospital, Odense University Hospital, University Hospital, Gentofte, Copenhagen, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00660478
Brief Title
Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients
Acronym
SORT-OUTIII
Official Title
Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Evald Hoej Christiansen
Collaborators
Aalborg University Hospital, Odense University Hospital, University Hospital, Gentofte, Copenhagen, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Zotarolimus eluting stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sirolimus stent
Intervention Type
Device
Intervention Name(s)
Endeavor
Other Intervention Name(s)
1. Endeavor
Intervention Description
Comparison of two different drug eluting coronary stents
Intervention Type
Device
Intervention Name(s)
Cypher Select
Other Intervention Name(s)
1. Cypher
Intervention Description
Comparison of two different drug eluting coronary stents
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens F Lassen, MD, PhD
Organizational Affiliation
Aarhus University Hospital Skejby
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Klaus Rasmussen, MD, DMSc
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus
ZIP/Postal Code
DK-8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24631162
Citation
Maeng M, Tilsted HH, Jensen LO, Krusell LR, Kaltoft A, Kelbaek H, Villadsen AB, Ravkilde J, Hansen KN, Christiansen EH, Aaroe J, Jensen JS, Kristensen SD, Botker HE, Thuesen L, Madsen M, Thayssen P, Sorensen HT, Lassen JF. Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial. Lancet. 2014 Jun 14;383(9934):2047-2056. doi: 10.1016/S0140-6736(14)60405-0. Epub 2014 Mar 14.
Results Reference
derived
PubMed Identifier
22917452
Citation
Maeng M, Tilsted HH, Jensen LO, Kaltoft A, Kelbaek H, Abildgaard U, Villadsen AB, Krusell LR, Ravkilde J, Hansen KN, Christiansen EH, Aaroe J, Jensen JS, Kristensen SD, Botker HE, Madsen M, Thayssen P, Sorensen 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.
Results Reference
derived
PubMed Identifier
21729834
Citation
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. doi: 10.4244/EIJV7I3A56.
Results Reference
derived
PubMed Identifier
20231034
Citation
Rasmussen K, Maeng M, Kaltoft A, Thayssen P, Kelbaek H, Tilsted HH, Abildgaard U, Christiansen EH, Engstrom T, Krusell LR, Ravkilde J, Hansen PR, Hansen KN, Abildstrom SZ, Aaroe J, Jensen JS, Kristensen SD, Botker HE, Madsen M, Johnsen SP, Jensen LO, Sorensen 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. doi: 10.1016/S0140-6736(10)60208-5. Epub 2010 Mar 16.
Results Reference
derived

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

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