NCT00388934

Brief Summary

Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,095

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_4 coronary-artery-disease

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

August 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 30, 2013

Status Verified

May 1, 2007

Enrollment Period

1.4 years

First QC Date

October 16, 2006

Last Update Submit

July 29, 2013

Conditions

Coronary Artery DiseaseAngina Pectoris

Keywords

Percutaneous coronary interventionAngina pectorisStent

Outcome Measures

Primary Outcomes (1)

  • MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)

    during 9 months

Secondary Outcomes (5)

  • Total death

    after 9 months, 2 and 3 years

  • Cardiac death

    after 9 months, 2 and 3 years

  • Myocardial infarction

    after 9 months, 2 and 3 years

  • Target vessel revascularisation, target lesion revascularisation, TVF

    after 9 months, 2 and 3 years

  • Stent thrombosis

    after 9 months, 2 and 3 years

Study Arms (2)

Drug eluting stent (Cypher)

EXPERIMENTAL

Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher)

Device: Drug eluting stent

Drug eluting stent (Taxus)

EXPERIMENTAL

Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus)

Device: Drug eluting stent

Interventions

Drug eluting stentDEVICE

percutaneous intervention with implantation of drug eluting coronary stent

Also known as: DES, Cypher, Taxus
Drug eluting stent (Cypher)Drug eluting stent (Taxus)

Eligibility Criteria

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

You may qualify if:

  • Planned implantation of drug eluting stent
  • Written informed consent

You may not qualify if:

  • Planned intervention with other stents than study stents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Galloe AM, Kelbaek H, Thuesen L, Hansen HS, Ravkilde J, Hansen PR, Christiansen EH, Abildgaard U, Stephansen G, Lassen JF, Engstrom T, Jensen JS, Jeppesen JL, Bligaard N; SORT OUT II Investigators. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents. J Am Coll Cardiol. 2017 Feb 14;69(6):616-624. doi: 10.1016/j.jacc.2016.11.055.

    PMID: 28183505DERIVED

  • Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16. doi: 10.1001/jama.299.4.409.

    PMID: 18230778DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAngina Pectoris

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Anders Galloe, MD

    Gentofte Hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 17, 2006

Study Start

August 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2009

Last Updated

July 30, 2013

Record last verified: 2007-05