Trials / Unknown
UnknownNCT03318796
Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 335 (estimated)
- Sponsor
- Tryton Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Accepted
Summary
TRYTON Post Approval Study (PAS) of the Tryton Side Branch Stent
Detailed description
The primary objective of this PAS is to assure the continued safety and effectiveness of the Tryton Side Branch Stent™ with main branch approved DES in the treatment of de novo native coronary artery bifurcation lesions with side branch diameter ranging from ≥2.5 mm to ≤3.5 mm and main branch diameter ranging from ≥2.5 mm to ≤4.0 mm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coronary Artery Stenting | Interventional coronary artery stent placement in De novo bifurcation lesions of the MB \& SB |
Timeline
- Start date
- 2018-01-22
- Primary completion
- 2019-12-30
- Completion
- 2022-12-30
- First posted
- 2017-10-24
- Last updated
- 2019-02-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03318796. Inclusion in this directory is not an endorsement.