The SOURT OUT IV TRIAL

Conditions

Coronary Atherosclerosis, Ischemic Heart Disease, Percutaneous Coronary Intervention

Keywords

PCI, Drug-eluting stent

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.

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.

Jensen LO, Thayssen P, Christiansen EH, Maeng M, Ravkilde J, Hansen KN, Hansen HS, Krusell L, Kaltoft A, Tilsted HH, Berencsi K, Junker A, Lassen JF, SORT OUT IV Investigators.

2016-02-0191 citations

10.1016/j.jacc.2015.11.051

Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial.

Jensen LO, Thayssen P, Maeng M, Christiansen EH, Ravkilde J, Hansen KN, Kaltoft A, Tilsted HH, Madsen M, Lassen JF, Scandinavian Organization for Randomized Trials With Clinical Outcome SORT OUT IV Investigators.

2014-07-3023 citations

10.1016/j.jcin.2014.02.014

Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV).

Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Hansen KN, Kaltoft A, Maeng M, Pedersen KE, Kristensen SD, Bøtker HE, Ravkilde J, Sanchez R, Aarøe J, Madsen M, Sørensen HT, Thuesen L, Lassen JF, Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV) Investigators.

2012-02-03115 citations

10.1161/circulationaha.111.063644

Interventions

DEVICEPercutaneous coronary intervention (Xience V stent)

Cypher Select plus coronary stent Xience V coronary stent

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization)	9 months, 1 year, 2 years, 3 years

Countries

Denmark

Outcome results

None listed