Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent

NCT03318796 | Unknown FDA Device

• 1 other identifier: P-0161
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

TRYTON Post Approval Study (PAS) of the Tryton Side Branch Stent

Conditions

Coronary Artery Disease

Keywords

Bifurcation lesions

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure (TVF)

  Composite of cardiac death, target vessel MI (Q and non-Qwave) clinically driven target vessel revascularization

  1 year

Secondary Outcomes (8)

• Device success

  48 hrs

• Lesion success

  48 hrs

• Procedure success

  48 hrs

• Death

  1 year

• Myocardial infarction (MI)

  1 year

Study Arms (1)

Interventional

OTHER

Coronary artery stenting of De novo bifurcation lesions MB \& SB

Device: Coronary Artery Stenting

Interventions

Coronary Artery Stenting DEVICE

Interventional coronary artery stent placement in De novo bifurcation lesions of the MB \& SB

Interventional

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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; -

You may not qualify if:

• 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
• Left main coronary artery disease (protected and unprotected);
• Trifurcation lesion;
• Totally occluded target vessels (TIMI flow 0 or 1);
• Moderate to Severely calcified target lesion(s);
• Highly calcified target lesion(s) requiring rotational atherectomy;
• Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
• Angiographic evidence of thrombus in the target lesion(s);

Sponsors & Collaborators

• Tryton Medical, Inc.: lead

Study Sites (1)

NC Heart and Vascular Research/UNC REX

Raleigh, North Carolina, 27607, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Joel Schnieder, MD

  Rex Health; Raleigh NC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doug Ferguson

CONTACT

617-852-9565; dferguson@trytonmedical.com

Elizabeth Lavelle

CONTACT

508-822-8229; elavelle@trytonmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single arm open label registry

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 24, 2017
• Study Start: January 22, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2022
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

US (1)