Tryton Extended Access Registry

TRYTON PIVOTAL IDE Coronary Bifurcation Trial

Tryton Extended Access Registry [NCT01258972]

Description:  The Tryton Side Branch Stent System has been designed to address the procedural difficulty surrounding treatment of bifurcation lesions and to ensure patency of the side branch with similar performance capabilities (e.g., tracking, radiopacity, coverage and radial strength) that are currently available with conventional coronary stents designed for straight (non bifurcation) lesions.

The Tryton Side Branch Stent is intended to treat and maintain patency in the side branch/carina by providing better ostial side branch conformability and is intended for use in conjunction with currently approved balloon-expandable drug-eluding stents for treatment of the main branch.

Device: Tryton Side Branch Stent with main branch DES

 


Primary Investigator: Kereiakes

Drug/Device Information
The primary objective of this extended access registry is to assure the continued safety and effectiveness of the Tryton Side Branch Stent
The Tryton Side Branch Stent is a dedicated side branch bare metal stent composed entirely of L605 Cobalt Chromium Alloy
Three zones: a Side Branch zone that is deployed within the side branch, a Transition Zone that resides at the side branch ostium, and a Main Branch Zone, which is placed within the main branch
Non randomized, all subjects enrolled will receive the Tryton Side Branch Stent with main branch approved DES
Tryton Medical, Inc.
Major Inclusion and Exclusion
The patient must be ≥ 18 and ≤ 90 years of age
Acceptable candidate for CABG
Bifurcation lesion main branch reference vessel diameter must be ≥ 2.5 mm to ≤ 4.0 mm
Side branch reference vessel diameter must be ≥ 2.5mm and <3.5 mm by visual estimate
Bifurcation lesion main branch lesion length ≤ 28 mm and side branch lesion length ≤ 5.0 mm
No STEMI acute myocardial infarction (AMI) within 72 hours
No creatinine >2.5 mg/dL
No Platelet count <100,000 cells/mm3 or >700,000 cells/mm3