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The SOURT OUT IV TRIAL (SORT OUT IV)

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00552877
First received: October 31, 2007
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

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 Intervention
Ischemic Heart Disease
Coronary Atherosclerosis
Percutaneous Coronary Intervention
Device: Percutaneous coronary intervention (Xience V stent)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

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

Estimated Enrollment: 2678
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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 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
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: 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

No publications provided by Odense University Hospital

Additional 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
Study First Received: October 31, 2007
Last Updated: August 12, 2009
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 19, 2014