Status:
UNKNOWN
Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
Lead Sponsor:
Tryton Medical, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- The patient must be ≥18 and ≤ 90 years of age;
- Acceptable candidate for CABG;
- The intention to treat the side branch of the target bifurcation based on angiographic evaluation
- The patient is willing to comply with specified follow-up evaluations;
- 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).
- Planned use of FDA approved and commercially available drug-eluting stents (DES) for subject's index procedure Angiographic Inclusion Criteria
- 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;
- Target lesion located in a native coronary artery;
- 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);
- 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);
- Target lesion ≥50% and \<100% stenosed by visual estimate in both the main branch and side branch; -
Exclusion
- General Exclusion Criteria
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
- Impaired renal function (serum creatinine \>2. mg/dL or 150 μmol/l);
- Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis);
- Presence of a heart transplant
- Known allergy to cobalt chromium
- Hypersensitivity or contraindication to cobalt-chromium or structurally-related compounds, cobalt, chromium, nickel, or tungsten
- Anticipated use of rotational artherectomy
- Patient in whom the use of a drug eluting stent is contraindicted, e.g., who cannot receive the recommended dual anti-platelet (aspirin and an approved P2Y12 inhibitor) and/or anticoagulant therapy
- Angiographic
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT03318796
Start Date
January 22 2018
End Date
December 30 2022
Last Update
February 26 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NC Heart and Vascular Research/UNC REX
Raleigh, North Carolina, United States, 27607