Ignite Creation Date:
2024-05-05 @ 11:06 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01258972
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2010-12-09
Brief Title:
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
Sponsor:
Tryton Medical Inc
Organization:
Tryton Medical Inc
Study Overview
Official Title:
TRYTON PIVOTAL IDE Coronary Bifurcation Extended Access Study
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRYTON
Brief Summary:
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 eg 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 branchcarina 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
The Tryton Side Branch Stent is intended to treat and maintain patency in the side branchcarina 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None