Tryton I, A first in man clinical evaluation of the TRYTON * Sidebranch stent.

Tryton I, A first in man clinical evaluation of the TRYTON * Sidebranch stent. - Tryton I

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30192

Enrollment

Registered

2006-10-05

Start date

2006-10-11

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

bifurcation

Interventions

The Tryton sidebranch stent is developed to treat bifurcation lesions. The Tryton stent itself will be placed in the sidebranch. The Cypher stent will be placed in the main vessel.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients from 18- 85 years of age. Patients with symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia. Treatment of a single de novo lesion involving a side branch. Main vessel target lesion is located in a native coronary artery.

Exclusion criteria

Exclusion criteria: Totally occluded vessel Excessive tortuousity Evidence of thrombus A significant > 50% stenosis proximal or distal to the target lesion. Females who are pregnant or nursing or females of childbearing potential

Design outcomes

Primary

Measure	Time frame
Composite Endpoint- Procedural Success - Successful deployment of the Tryton sidebranch - Angiographic Success:	—

Secondary

Measure	Time frame
Clinical Parameters: - Non-MACE, Serious Adverse Events (SAE) at hospital discharge - MACE and Anginal Status at post procedure and up to nine (9) months Angiographic Parameters - Acute IVUS Success - Angiographic restenosis at six months - Volumetric Late Loss by IVUS at six months - In-stent and vessel segment percentage DS (diameter stenosis) post-procedure	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)