NCT01174433

Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and feasibility of the use of the Tryton bifurcation coronary stent system for the treatment of single de novo bifurcation lesions in native coronary arteries.

Detailed description

Currently available stents were designed for straight lesions, optimised to provide scaffolding (coverage and radial strength) and ease of deliverability. In straight lesions, these stents have been shown to provide superb acute and long-term results. One lesion subset that continues to challenge the interventionalist is bifurcations lesions. A number of different strategies have been employed with standard stents to address bifurcation lesions each of which have significant limitations. Large contemporary registries characterising current stent usage in bifurcating lesions have demonstrated decreased procedural success with increased rates in restenosis and thrombosis (acute, subacute and delayed). The limitations of currently available stents have led groups to develop stents designed specifically to treat bifurcation lesions. The Tryton Side-Branch Stent Stent TM (Tryton Medical, Inc., Newton, MA, USA) is a balloon expandable cobalt chromium stent, designed specifically to treat bifurcation lesions. The primary objective of this study is to evaluate the safety and feasibility of the use of the Tryton bifurcation coronary stent system for the treatment of single de novo bifurcation lesions in native coronary arteries with reference vessel diameters (RVD) for the proximal main vessel of 2.5 - 5.0 mm, distal main branch of 2.5 - 5.0 mm, and side branch RVD 2.5 - 3.5 mm.

Conditions

• Coronary Artery Disease
• Angioplasty, Transluminal, Percutaneous Coronary

Interventions

Type	Name	Description
DEVICE	Tryton	Percutaneous coronary intervention of a bifurcation lesion, with a Tryton bifurcation coronary stent for the side branch and a drug-eluting coronary stent for the main branch

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-08-03
• Last updated: 2012-07-04

Locations

6 sites across 1 country: Italy