A Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety And Effectiveness of the Tryton Side Branch Stent™ used in Conjunction with a Drug-Eluting Stent Compared to Side Branch Balloon Angioplasty in Conjunction with a Drug-Eluting Stent in the Treatment of de novo Bifurcation Lesions Involving the Main Branch and Side Branch within the Native Coronary Circulation (TRYTON side-branch stent TRIAL)
ID Number 11-0705Principal Investigator(s)
Samin K Sharma
Department(s) or Division(s)
The purpose of this clinical study is to evaluate the safety and effectiveness of the Tryton Side Branch investigational stent. This study will evaluate a new stent design that is designed to treat narrowing in coronary arteries that occur in the main body of the coronary artery and in one of the side branches of the artery. The Tryton Side Branch stent is intended to be used with an FDA approved drug-eluting stent (DES) that is placed in the main body of the blood vessel. A drug-eluting stent has a drug coating or filling that is meant to prevent tissue re-growth where the stent is placed. The Tryton Side Branch Stent does not have a drug coating. The investigational stent is not approved by the FDA for use in treating narrowed coronary arteries outside of this clinical study. The results seen with implant of the Tryton Side Branch stent plus an approved DES will be compared to those seen in patients who are treated with balloon angioplasty alone in the side branch lesion and an approved DES in the main vessel lesion. The follow ups will be done at 30 day (visit), 6 month telephone follow-up, 9 month telephone follow-up (visit), 1 to 5-year follow-ups (telephone calls).
Recruiting Patients: Yes