NCT00840775

PIONIR Study (Presillion™ and Presillion™ Plus Stent Systems)

Clinical Protocol Presillion™ and Presillion™ Plus Stent Systems

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Medinol Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect and analyze additional information about the safety and effectiveness of the Presillion™ Stent System in the treatment of de novo stenotic lesions in native coronary arteries.

Detailed description

This is a post market, non-randomized, multi-center, prospective, single arm clinical study that will be conducted at up to 25 sites in Europe and Israel. All patients will be followed at 30 days, 6 months, 9 months and 1 year post index stenting procedure. The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the Presillion™ Stent System. This rate will be compared with a performance goal derived using a meta-analysis of the standard-of-care therapy, coronary stenting with bare metal stents. This data will be used to support the PMA application for the Presillion™ Stent System.

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
DEVICE	Catheterization, stent deployment	Standard catheterization procedure including Bare Metal Stent deployment.

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-01-01
• Completion: 2011-06-01
• First posted: 2009-02-10
• Last updated: 2018-03-27

Locations

16 sites across 4 countries: Belgium, Germany, Israel, Sweden