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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00722579 |
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 post-procedure for assessment of MACE and all other adverse events.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: PRESILLION cobalt chromium stent |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Non-Randomized, Multi-Center, Single-Arm Safety Study of the Presillion Stent in de Novo Native Coronary Artery Lesions |
Enrollment: | 101 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | April 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
The PRESILLION TM Coronary Stent is an L-605 cobalt chromium (CoCr) stent.
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Device: PRESILLION cobalt chromium stent
PTCA with bare-metal stent
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cordis ( Hans-Peter Stoll, MD ) |
Study ID Numbers: | EC08-01 |
Study First Received: | July 24, 2008 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00722579 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Chromium Cobalt |
Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |