Prospective, Single Blind, Rand Controlled Study to Evaluate the Safety & Effectness of Tryton Side Branch Stent Used With DES Treatmt of de Novo Bifurcation Lesions in MB & SB in Native Coronaries (TRYTON)
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.
|Coronary Atherosclerosis of Native Coronary Artery Bifurcation Lesions: de Novo Lesions of the Main and Side Branch of Native Coronary Artery||Device: Tryton Side Branch Stent with main branch DES Device: POBA|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||TRYTON PIVOTAL IDE Coronary Bifurcation Extended Access Study|
- Target Vessel Failure (TVF) [ Time Frame: 9 months ]
- In-segment % diameter stenosis of the Tryton SB compared to side branch balloon angioplasty [ Time Frame: 9 months ]
- Periprocedural MI after PCI, CK-MB elevation with value >3X times the upper range limit within the first 48 hrs after PCI [ Time Frame: 48 hours post PCI ]Extended Access Registry is the extension of the Prospective multicenter, randomized, controlled study designed to enroll up to 133 subjects treated with the tryton Side Branch Stent with main branch approved DES for treatment of native coronary artery bifurcation disease in lesions >/= 2.5mm RVD
|Study Start Date:||December 2010|
|Study Completion Date:||October 2016|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Angioplasty POBA
Side Branch balloon angioplasty with main branch DES
Experimental: Tryton Side Branch Stent
Side Branch treated with Tryton Side Branch Stent with main branch DES
Device: Tryton Side Branch Stent with main branch DES
Tryton Side Branch Stent
The use of drug-eluding stents in the treatment of bifurcation lesions suggests that DES reduces the rate of restenosis int he main branch (5-10%); however, results int he side branch are not optimal. A study of T stenting in true bifurcation lesions showed a restenosis rate int he main branch of approximately 6% using the CYPHER stent. However, the same study demonstrated that the restenosis rate remained high int he side branch (20%) despite stent implantation and when restenosis occurs, it is generally located at the ostium of the side branch. Further, in half the cases where PTCA alone was the intended strategy for the side branch, a side branch stent had to be placed to address sub-optimal procedural results.
These findings are consistent with previous metal stent studies and suggest the best long-term results are obtained when a side branch stent is not placed. This study and others suggest that the outcomes are related to the way the stents sit within in the vessel; and therefore a stent designed specifically for bifurcation lesions will be needed to reduce restenosis rates and improve long-term outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258972
|United States, New York|
|New York City, New York, United States, 10032|
|Principal Investigator:||Martin B. Leon, M.D.||Columbia University|