NCT00660478

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,342

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 29, 2013

Status Verified

September 1, 2008

Enrollment Period

1.9 years

First QC Date

April 9, 2008

Last Update Submit

August 28, 2013

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 months

Secondary Outcomes (1)

  • To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months.

    9 months

Study Arms (2)

1

ACTIVE COMPARATOR

Zotarolimus eluting stent

Device: Endeavor

2

ACTIVE COMPARATOR

Sirolimus stent

Device: Cypher Select

Interventions

EndeavorDEVICE

Comparison of two different drug eluting coronary stents

Also known as: 1. Endeavor
1
Cypher SelectDEVICE

Comparison of two different drug eluting coronary stents

Also known as: 1. Cypher
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus, DK-8200, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 24631162DERIVED

  • 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.

    PMID: 22917452DERIVED

  • 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.

    PMID: 21729834DERIVED

  • 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.

    PMID: 20231034DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jens F Lassen, MD, PhD

    Aarhus University Hospital Skejby

    STUDY CHAIR

  • Klaus Rasmussen, MD, DMSc

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 9, 2008

First Posted

April 17, 2008

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

October 1, 2009

Last Updated

August 29, 2013

Record last verified: 2008-09

Locations

DK(1)