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

ClinicalTrials.gov ID: NCT01258972

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Official title

TRYTON PIVOTAL IDE Coronary Bifurcation Extended Access Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01258972
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: Tryton Medical, Inc.; Industry
Enrollment: 133 participants

Conditions and interventions

Conditions

Interventions

Tryton Side Branch Stent with main branch DES Device
POBA Device

Device

Eligibility (public fields only)

Age range: 18 Years to 90 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 2010 (Type not available)
Primary completion: Nov 2014 (Actual)
Completion: Oct 2016 (Actual)
Last update posted: Oct 18, 2016

2010 – 2016

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Jeffery Moses	New York	New York	10032	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01258972, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 18, 2016 · Synced Nov 11, 2026