Coronary Artery Stenosis Clinical Trial
Official title:
Intravenous Liposomal Alendronate Infusion in Subjects Undergoing Bare Metal Coronary Stent Implantation
The main objective of this study is to assess the safety and efficacy of Liposomal
Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a
population undergoing PCI with implantation of a bare metal stent.
Study hypothesis: Liposomal Alendronate will reduce in-stent restenosis as compared to
placebo.
This is a Phase II dose-finding, randomized, multi-center, prospective, double blind
clinical study. Subjects undergoing percutaneous coronary intervention (PCI) with the
Presillion™ CoCr bare metal stent will be randomized into three groups and administered (in
a single dose intravenously (IV) through a peripheral venous catheter) either: low dose
Liposomal Alendronate of 0.001 mg, high dose Liposomal Alendronate of 0.01 mg, or placebo
(IV saline infusion) on a 1:1:1 basis.
All subjects will undergo angiographic follow-up at 6 months and 110 subjects enrolled from
pre-specified sites will undergo intravascular ultrasound (IVUS) at baseline and follow-up
at 6 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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