NCT00152308

Brief Summary

The purpose of the study is to evaluate the effectively of coating of coronary stents with two different doses of rapamycin for the prevention of coronary vessel re-blockage

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
333

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2004

Typical duration for phase_4

Geographic Reach
3 countries

10 active sites

Status
terminated

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

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

October 8, 2020

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

October 6, 2020

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

  • Binary angiographic restenosis at follow-up angiogram

Secondary Outcomes (1)

  • Target vessel failure (all-cause death, myocardial infarction, or revascularization of the target lesion)

Interventions

2% rapamycin-eluting YUKONdes PEARL-stentDEVICE
1% rapamycin-eluting YUKONdes PEARL-stentDEVICE
YUKONdes PEARL-stent coated with placebo (ethanol)DEVICE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-85 years; Symptoms (stable or unstable angina) or signs of myocardial ischemia; Single de novo diagnosed lesion in a native coronary artery (50-99% DS); Lesion length 8 - 25 mm; Vessel diameter 2.25-3.75 mm; Written informed consent

You may not qualify if:

  • Left main target lesion unprotected by a graft; Ostial and bifurcation target lesion; Severely calcified lesions; Thrombus in target lesion; Tortuosity or angulation of target vessel or lesion; Treatment of nontarget lesions in the same or a different coronary vessel during the index procedure; Contraindications to the study medications; Acute myocardial infarction (\< 48 h); Left ventricular ejection fraction \< 25%; Participation in another trial; Pregnancy or lack of protection against pregnancy during the study Coexisting conditions limiting the life expectancy to less 24 months or that could affect the compliance of patients with protocol; Serum creatinin \>2.0mg/dL; Hemorrhagic diathesis; Leukocyte count \<3500/ml\^3 Platelet count \<100.000/ml\^3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

St. Johanns Spital

Salzburg, 5020, Austria

Location

Donauspital der Stadt Wien

Vienna, 1020, Austria

Location

Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

Wilhelminenspital der Stadt Wien

Vienna, 1160, Austria

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Kardiologische Praxis und Praxisklinik

Munich, 81379, Germany

Location

First Medizinische Klinik rechts der Isar

Munich, 81675, Germany

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Assaf Harofeh Medical Center

Zrifin, 70300, Israel

Location

Related Publications (3)

  • 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

  • Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.

    PMID: 12050336BACKGROUND

  • Tanabe K, Serruys PW, Grube E, Smits PC, Selbach G, van der Giessen WJ, Staberock M, de Feyter P, Muller R, Regar E, Degertekin M, Ligthart JM, Disco C, Backx B, Russell ME. TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation. 2003 Feb 4;107(4):559-64. doi: 10.1161/01.cir.0000048184.96491.8a.

    PMID: 12566366BACKGROUND

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

  • Kurt Huber, MD

    Wilhelminenspital der Stadt Wien

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

December 1, 2004

Study Completion

February 1, 2007

Last Updated

October 8, 2020

Record last verified: 2005-09

Locations

AU(4)DE(3)IL(3)