Coronary Artery Disease
Conditions
Keywords
Bifurcation lesions
Brief 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.
Interventions
DEVICECoronary Artery Stenting
Interventional coronary artery stent placement in De novo bifurcation lesions of the MB & SB
Sponsors
Tryton Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single arm open label registry
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
General Inclusion Criteria 1. The patient must be ≥18 and ≤ 90 years of age; 2. Acceptable candidate for CABG; 3. The intention to treat the side branch of the target bifurcation based on angiographic evaluation 4. The patient is willing to comply with specified follow-up evaluations; 5. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Institutional Review Board (IRB). 6. Planned use of FDA approved and commercially available drug-eluting stents (DES) for subject's index procedure Angiographic Inclusion Criteria 7. a) Single de novo lesion in a bifurcation involving both the main branch and the side branch b) The bifurcation: main branch and side branch with a visual diameter stenosis ≥ 50% (Medina classification 1.1.1; 0.1.1; 1.0.1) by visual assessment; 8. Target lesion located in a native coronary artery; 9. a) Bifurcation lesion main branch reference vessel diameter must be ≥2.5 mm to ≤ 4.0 mm, and b) Side branch reference vessel diameter must be ≥2.5mm by visual estimate (≥2.25mm by QCA) and \<3.5 mm by visual estimate (\<3.25 mm by QCA); 10. a) Bifurcation lesion main branch lesion length ≤ 28 mm and b) Side branch lesion length ≤ 5.0 mm (the ability to be treated with a single stent for both main and side branch); 11. Target lesion ≥50% and \<100% stenosed by visual estimate in both the main branch and side branch; -
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) | 1 year | Composite of cardiac death, target vessel MI (Q and non-Qwave) clinically driven target vessel revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success | 48 hrs | Attainment of \<30% residual stenosis within the side branch without device malfunction |
| Lesion success | 48 hrs | Attainment of \<30% residual stenosis using any percutaneous method |
| Death | 1 year | All-cause and cardiac mortality |
| Procedure success | 48 hrs | Lesion success without the occurrence of in-hospital MACE |
| CD-TLR | 1 year | Clinically driven target lesion revascularization |
| CD-TVR | 1 year | Clinically driven target vessel revascularization |
| Stent thrombosis | 1 year | ARC definition of definite and probable |
| Myocardial infarction (MI) | 1 year | Q wave and Non-Q wave |
Countries
United States
Contacts
Primary ContactDoug Ferguson
Backup ContactElizabeth Lavelle
Outcome results
None listed