NCT00146575

Brief Summary

The purpose of this study is to compare the efficacy of paclitaxel- and sirolimus-eluting stents to prevent re-blockage of small coronary arteries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

2 active sites

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

June 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
Last Updated

January 11, 2008

Status Verified

January 1, 2008

First QC Date

September 6, 2005

Last Update Submit

January 10, 2008

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

  • Late luminal loss

    6 months

Secondary Outcomes (2)

  • Binary angiographic restenosis

    1 year

  • Target lesion revascularization

    1 year

Study Arms (2)

1

EXPERIMENTAL

randomized patients get sirolimus stent

Device: Sirolimus-eluting stent (Cypher)

2

EXPERIMENTAL

randomized patients get paclitaxel stent

Device: Paclitaxel-eluting stent (Taxus)

Interventions

Sirolimus-eluting stent (Cypher)DEVICE

patients have been implanted a Cypher stent

Also known as: Cypher
1
Paclitaxel-eluting stent (Taxus)DEVICE

patients have been implanted a Taxus stent

Also known as: Taxus
2

Eligibility Criteria

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

You may qualify if:

  • Stable or unstable angina pectoris and/or a positive stress test
  • "de novo" lesion in small coronary arteries (vessel size \<2.8 mm by visual estimation)
  • Written informed consent

You may not qualify if:

  • Diabetes mellitus
  • Myocardial infarction within 48 h. before enrollment
  • Target lesion located in the left main trunk or bypass graft
  • Contraindication or known allergy to aspirin, thienopyridines, rapamycin, paclitaxel or stainless steel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Deutsches Herzzentrum

Munich, 80636, Germany

Location

Related Publications (5)

  • Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.

    PMID: 14523139BACKGROUND

  • Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.

    PMID: 14724301BACKGROUND

  • Kastrati A, Dibra A, Eberle S, Mehilli J, Suarez de Lezo J, Goy JJ, Ulm K, Schomig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA. 2005 Aug 17;294(7):819-25. doi: 10.1001/jama.294.7.819.

    PMID: 16106007BACKGROUND

  • Morice MC. Stenting for small coronary vessels. J Invasive Cardiol. 2003 Jul;15(7):377-9. No abstract available.

    PMID: 12840233BACKGROUND

  • Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schomig A; Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J. 2006 Feb;27(3):260-6. doi: 10.1093/eurheartj/ehi721. Epub 2006 Jan 9.

    PMID: 16401670RESULT

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Albert Schomig, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Adnan Kastrati, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

June 1, 2003

Study Completion

February 1, 2005

Last Updated

January 11, 2008

Record last verified: 2008-01

Locations

DE(2)