NCT02765646

eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries

eTryton Left Main Multi-center, Prospective, Non-randomized Single Arm Registry Evaluating the Tryton Side Branch Stent® for Treatment of de Novo CAD in Both LM and Circumflex (LCX) Coronary Arteries

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Tryton Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to demonstrate the clinical performance of the Tryton Side Branch Stent used in conjunction with a commercially available Drug Eluting Stent (DES) to treat de novo bifurcated lesions involving both the Left Main (LM) and Circumflex Coronary Artery(LCX).

Detailed description

The registry study will involve the collection of demographic and clinical data, including in-hospital and follow-up data to determine primary composite endpoint of MACE (Major Adverse Cardiac Events) at 9 months and secondary endpoints. Secondary endpoints are defined as successful deployment of the Tryton stent and main vessel DES within the target lesion, angiographic success \<30% residual stenosis in LM and LAD/LCX by visual estimate and TIMI 3 flow post procedure, and freedom of in-hospital MACE.

Conditions

• Left Main Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Coronary stent procedure (CSP)

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-06-01
• Completion: 2019-08-01
• First posted: 2016-05-06
• Last updated: 2019-04-26

Locations

1 site across 1 country: Germany