A Study of the Presillion Stent in de Novo Coronary Lesions (PRESILLION)
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.
|Coronary Artery Disease||Device: PRESILLION cobalt chromium stent||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Non-Randomized, Multi-Center, Single-Arm Safety Study of the Presillion Stent in de Novo Native Coronary Artery Lesions|
- 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 ]
- Stroke. [ Time Frame: Post-procedure ]
|Study Start Date:||July 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
The PRESILLION TM Coronary Stent is an L-605 cobalt chromium (CoCr) stent.
Device: PRESILLION cobalt chromium stent
PTCA with bare-metal stent
Other Name: bare-metal stent
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722579
|CHU de Liège|
|Liège, Belgium, B-4000|
|Principal Investigator:||V. Legrand, MD, Phd||CHU de Liège|