Status:
TERMINATED
Non-Polymer-Based, Rapamycin-Eluting Stents to Prevent Restenosis
Lead Sponsor:
Translumina GmbH
Conditions:
Coronary Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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
Detailed Description
In-stent restenosis remains the major problem limiting the efficacy of coronary stenting. Either sirolimus or paclitaxel drug-eluting stents have been demonstrated to decrease neointima proliferation ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT00152308
Start Date
December 1 2004
End Date
February 1 2007
Last Update
October 8 2020
Active Locations (10)
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1
St. Johanns Spital
Salzburg, Austria, 5020
2
Donauspital der Stadt Wien
Vienna, Austria, 1020
3
Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
4
Wilhelminenspital der Stadt Wien
Vienna, Austria, 1160