Clinical trial NCT00660478: Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients
Official title: Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Heart Disease
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Odense University Hospital
name: University Hospital, Gentofte, Copenhagen
name: Rigshospitalet, Denmark
First posted: 2008-04-17
Enrollment: 2342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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.
timeFrame: 9 months
Secondary outcomes:
measure: To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months.
timeFrame: 9 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Jens F Lassen, MD, PhD
role: STUDY_CHAIR
affiliation: Aalborg University Hospital
name: Klaus Rasmussen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.