NCT00140530

Brief Summary

The purpose of this study is to assess the efficacy of nonpolymer-based rapamycin-eluting stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of coronary arteries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

January 11, 2008

Status Verified

January 1, 2008

First QC Date

August 31, 2005

Last Update Submit

January 10, 2008

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

  • In-stent late luminal loss

    6 months

Secondary Outcomes (2)

  • Angiographic restenosis at follow-up angiography

    6 months

  • Need for target lesion revascularization due restenosis at 9 months

    9 months

Study Arms (2)

1

EXPERIMENTAL

Due to randomisation patients got a Paclitaxel-eluting stent

Device: Paclitaxel-eluting stent (Taxus)

2

EXPERIMENTAL

Due to randomization patients got a Rapamycin-eluting stent.

Device: Rapamycin-eluting stent

Interventions

Paclitaxel-eluting stent (Taxus)DEVICE

patients has been implanted the Paclitaxel-eluting stent.

Also known as: Taxus
1
Rapamycin-eluting stentDEVICE

patients has been implanted the Rapamycin-eluting stent.

2

Eligibility Criteria

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

You may qualify if:

  • Patients at least 18 years old
  • Stable or unstable angina or a positive stress test
  • "de novo" coronary artery lesions
  • Written informed consent

You may not qualify if:

  • Myocardial infarction within 48 h. before enrollment
  • Target lesion located in left main trunk
  • Contraindication or known allergy to aspirin, heparin, 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

First Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (6)

  • Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schomig A; investigators of the individualizable durg-eluting Stent System to Abrogate Restenosis Project. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J. 2005 Aug;26(15):1475-81. doi: 10.1093/eurheartj/ehi405. Epub 2005 Jun 23.

    PMID: 15975990BACKGROUND

  • 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

  • Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, Kolodgie FD, Colombo A. Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation. 2002 Nov 19;106(21):2649-51. doi: 10.1161/01.cir.0000041632.02514.14.

    PMID: 12438288BACKGROUND

  • Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26.

    PMID: 14744976BACKGROUND

  • Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schomig A; Intracoronary Stenting and Angiographic Restenosis--Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation. 2006 Jan 17;113(2):273-9. doi: 10.1161/CIRCULATIONAHA.105.575977. Epub 2006 Jan 3.

    PMID: 16391155RESULT

  • King L, Byrne RA, Mehilli J, Schomig A, Kastrati A, Pache J. Five-year clinical outcomes of a polymer-free sirolimus-eluting stent versus a permanent polymer paclitaxel-eluting stent: final results of the intracoronary stenting and angiographic restenosis - test equivalence between two drug-eluting stents (ISAR-TEST) trial. Catheter Cardiovasc Interv. 2013 Jan 1;81(1):E23-8. doi: 10.1002/ccd.24375. Epub 2012 May 4.

    PMID: 22431239DERIVED

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

August 31, 2005

First Posted

September 1, 2005

Study Start

March 1, 2004

Study Completion

June 1, 2005

Last Updated

January 11, 2008

Record last verified: 2008-01

Locations

DE(2)