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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
PTCA with bare-metal stent
CHU de Liège
Liège, Belgium
Composite of MACE which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR).
Time frame: 1-month and 6-months post-procedure
Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion.
Time frame: 1-month and 6-months post-procedure
Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel.
Time frame: 1-month and 6-months post-procedure
Target Vessel Failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
Time frame: 1-month and 6-months post-procedure
Myocardial Infarction (MI).
Time frame: 1-month and 6-months post-procedure
Major bleeding.
Time frame: 1-month and 6-months post-procedure
Device success.
Time frame: Post-procedure
Lesion success.
Time frame: Post-procedure
Procedure success.
Time frame: Post-procedure
Incidence of acute and sub-acute stent thrombosis according the ARC definition.
Time frame: 1-month and 6-months post-procedure
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Stroke.
Time frame: Post-procedure