Coronary Artery Disease Clinical Trial
Official title:
A Non-Randomized, Multi-Center, Single-Arm Safety Study of the Presillion Stent in de Novo Native Coronary Artery Lesions
The PRESILLION Study is a non-randomized, multi-center, single-arm study evaluating the
safety of an approved Cobalt Chromium bare metal stent system for the treatment of ischemic
heart disease attributable to a stenotic de novo lesion in a native coronary artery.
The study population will include 100 patients with up to two de novo native coronary artery
lesions with a maximum lesion length of 30mm in a maximum of two major coronary arteries
with reference vessel diameter >= 2.5mm and <= 4.0mm by visual estimation. Patients will be
followed for 1 month and 6 month post-procedure for assessment of MACE and all other adverse
events.
The PRESILLION Stent System is intended for use in patients with symptomatic ischemic heart
disease attributable to stenotic de novo lesions of native coronary arteries with reference
vessel diameter from 2.5 mm to 4.0 mm with a lesion length up to 30 mm that are amenable to
percutaneous treatment with coronary stenting. The stent is intended as a permanent
implanted device.
The primary objective of this study is to evaluate the safety of the PRESILLION Stent System
in the treatment of de novo stenotic lesions in native coronary arteries. The primary safety
measure is the composite of MACE up to one (1) month follow up. The MACE rate shall meet the
performance goal for bare metal stents in order to show the safety of the device.
The protocol has been amended and data will be collected for a time point as close as
possible to (but after) the 6 months post index procedure in a non-interventional and
retrospective manner. The data point will contain exactly the same follow-up information as
was collected during the 1 month follow-up.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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