NCT02800837

Clinical Study to Evaluate the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

Multicenter Prospective Clinical Study of the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Stentys · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-randomized, multi-center study assessing the long term safety and efficacy of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected left main coronary artery disease.

Detailed description

In the treatment of unprotected left main coronary artery (ULMCA) disease, previous mono-center studies have shown promising results with the previous generation of the self-expandable STENTYS stent (paclitaxel eluting stent, delivered via withdrawal of a sheath). The TRUNC study aims at assessing at large scale the Xposition S in the treatment of ULMCA disease. The Xposition S is a sirolimus eluting stent, mounted on a balloon delivery system. The study aims at collecting clinical practice routine data from 200 patients.

Conditions

• Coronary Artery Disease (Left Main)

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-06-01
• Completion: 2019-06-01
• First posted: 2016-06-15
• Last updated: 2016-06-15

Locations

4 sites across 3 countries: Italy, Switzerland, United Kingdom