Tryton I, A first in man clinical evaluation of the TRYTON * Sidebranch stent.
Completed
- Conditions
- bifurcation10011082
- Registration Number
- NL-OMON30192
- Lead Sponsor
- Tryton Medical, Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite Endpoint- *Procedural Success*<br /><br>- Successful deployment of the Tryton sidebranch<br /><br>- Angiographic Success: <30% residual stenosis in main vessel and sidebranch<br /><br>and TIMI 3 flow post-procedure<br /><br>- Without in-hospital Major Adverse Cardiac Event (MACE)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Clinical Parameters:<br /><br><br /><br>- Non-MACE, Serious Adverse Events (SAE) at hospital discharge<br /><br>- MACE and Anginal Status at post procedure and up to nine (9) months<br /><br><br /><br><br /><br>Angiographic Parameters<br /><br>- Acute IVUS Success<br /><br>- Angiographic restenosis at six months<br /><br>- Volumetric Late Loss by IVUS at six months<br /><br>- In-stent and vessel segment percentage DS (diameter stenosis) post-procedure</p><br>