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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
226
IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours
IV in a single high dose during the index procedure (coronary stent implantation) over 2 hours
IV saline infusion during the index procedure (coronary stent implantation) over 2 hours
Hillel Yaffe Medical Center
Hadera, Israel
Bnei Zion Medical Center
Haifa, Israel
Rambam Health Care Campus
Haifa, Israel
In-stent late loss: measured at 6 months post-procedure as determined by quantitative coronary angiography (QCA).
Time frame: 6 months post-procedure
Major Adverse Cardiac Events (MACE)
Time frame: at 30, 180 and 360 days as well as yearly through 5 years post-procedure
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...and 2 more locations