Coronary Artery Disease Clinical Trial
Official title:
First In Man Evaluation of the Vesta™ & VestaCOR™ (Hydroxy-Apetite Coated genX™) Stent for Treatment of de Novo Native Coronary Artery Lesion(s)
The purpose of this first feasibility study is to evaluate the performance of Vesta™ &
VestaCOR™ (Hydroxy-Apetite coated GenX) stent in de novo native coronary artery lesions.
This study will provide the longest follow-up experience available.
This is a randomized, double blind study conducted at three sites, two sites in India and
one in The Netherlands. To be eligible, a patient will be required to have a de novo
stenotic lesion of a length that could be covered by a single stent in a native coronary
artery of diameter 3.0mm and 3.5mm. A total of at least 60 patients and a maximum of 70
patients will be treated with Vesta™ & VestaCOR™ stent. These patients will be randomized to
either a smooth surface nanofilm coated stent (= VestaCOR™) (approx. 35 patients) or to a
porous coated stent (= Vesta™) (approx. 35 patients).
All patients will be followed clinically at 30 days, 4 months, 9 months, 1, 2, 3, 4 and 5
years.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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