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

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 - A 9 months OCT and 3D QCA follow up study of Tryton stent.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35834

Enrollment

Registered

2011-10-24

Start date

2012-02-21

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bifurcation stenosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
• Strut apposition as predictor strut uncoverage.	—

Secondary

Measure	Time frame
• Correlation of strut apposition in different segments. • Maximum neointimal hyperplasia [NIH] thickness (µm) as predictor for Minimal lumen area (MLA, in mm2).	—

Countries

Netherlands

Outcome results