The SOURT OUT IV TRIAL (SORT OUT IV)

Odense University Hospital

Status: Completed

Conditions: Ischemic Heart Disease; Percutaneous Coronary Intervention; Coronary Atherosclerosis

Treatments: Device: Percutaneous coronary intervention (Xience V stent)

Study type: Interventional

Funder types: Other

Identifiers

NCT00552877

SOIV-20070043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,678 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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2,678 participants in 2 patient groups

1

Active Comparator group

Description:

Cypher Select plus stent

Treatment:

Device: Percutaneous coronary intervention (Xience V stent)

2

Active Comparator group

Description:

Xience V stent

Treatment:

Device: Percutaneous coronary intervention (Xience V stent)