NCT00722579

A Study of the Presillion Stent in de Novo Coronary Lesions

A Non-Randomized, Multi-Center, Single-Arm Safety Study of the Presillion Stent in de Novo Native Coronary Artery Lesions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	PRESILLION cobalt chromium stent	PTCA with bare-metal stent

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-12-01
• Completion: 2010-03-01
• First posted: 2008-07-25
• Last updated: 2010-06-14

Locations

1 site across 1 country: Belgium