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The SOURT OUT IV TRIAL (SORT OUT IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00552877
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : August 13, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher Select+ coronary stents in the treatment of unselected patients with coronary artery disease.

Condition or disease Intervention/treatment
Ischemic Heart Disease Coronary Atherosclerosis Percutaneous Coronary Intervention Device: Percutaneous coronary intervention (Xience V stent)

Detailed Description:

2 Purpose In a randomized study to compare the Cypher Select+ and the Xience V coronary stents in the treatment of unselected patients with coronary artery disease.

2.1 Primary objective In a randomized study to compare the Xience V and the Cypher Select+ coronary stents by assessing SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) and EFFICACY (target vessel revascularization) after 9 months.

2.2 Secondary objective To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months and the incidence of late stent thrombosis after 12, 24 and 36 months.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2678 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease
Study Start Date : August 2007
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Cypher Select plus stent
Device: Percutaneous coronary intervention (Xience V stent)
Cypher Select plus coronary stent Xience V coronary stent
Other Names:
  • Cypher Select plus coronary stent
  • Xience V coronary stent
Active Comparator: 2
Xience V stent
Device: Percutaneous coronary intervention (Xience V stent)
Cypher Select plus coronary stent Xience V coronary stent
Other Names:
  • Cypher Select plus coronary stent
  • Xience V coronary stent


Outcome Measures

Primary Outcome Measures :
  1. SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization) [ Time Frame: 9 months, 1 year, 2 years, 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.

Exclusion Criteria:

  • The patient will not participate
  • The patient participates in other randomised stent studies
  • Expected survival < 1 year
  • Allergy to Aspirin, Clopidogrel or Ticlopidine
  • Allergy to Sirolimus or ABT-578
Contacts and Locations

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): NCT00552877


Locations
Denmark
Odense University Hospital, Dept. of Cardiology
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Per Thayssen, MD DMSci Odense University Hospital, Dept. of Cardiology
More Information

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

Responsible Party: Per Thayssen, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00552877     History of Changes
Other Study ID Numbers: SOIV-20070043
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: August 13, 2009
Last Verified: August 2009

Keywords provided by Odense University Hospital:
PCI
Drug-eluting stent

Additional relevant MeSH terms:
Heart Diseases
Atherosclerosis
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease