A 9 months follow-up study of the Tryton Side branch Stent, a dedicated bifurcation stent, with optical coherence tomography and 3D quantitative coronary angiography

Completed

• Conditions: bifurcation stenosis; 10011082

• Registration Number: NL-OMON35834
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Patients with a bifurcation lesion which are treated with the Tryton Side Branch Stent.

Exclusion Criteria

general exclusion criteria:
1. Patients participating in the Tryton IDE trial.
2. Any intercurrent revascularization involving of the Tryton-treated bifurcation lesion
Exclusion criteria related to the optical coherence tomography:
1. Impaired renal function (eGFR <60 ml/min/1,73m2)
2. Any other contra-indication for Optical Coherence Tomography, at discretion of the operator

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Strut apposition as predictor strut uncoverage.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Correlation of strut apposition in different segments.<br /><br>• Maximum neointimal hyperplasia [NIH] thickness (µm) as predictor for Minimal<br /><br>lumen area (MLA, in mm2).</p><br>