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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Coronary Artery Stenting

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.

• Study Type: Interventional
• Enrollment (Anticipated): 335
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • NC Heart and Vascular Research/UNC REX
      • Contact: Joel Schneider, M.D.; Phone Number: 919-787-5380; Email: joel.schneider@unchealth.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Exclusion Criteria

1. 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;
2. Impaired renal function (serum creatinine >2. mg/dL or 150 μmol/l);
3. 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);
4. Presence of a heart transplant
5. Known allergy to cobalt chromium
6. Hypersensitivity or contraindication to cobalt-chromium or structurally-related compounds, cobalt, chromium, nickel, or tungsten
7. Anticipated use of rotational artherectomy

8. 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 Exclusion Criteria:

9. Left main coronary artery disease (protected and unprotected);
10. Trifurcation lesion;
11. Totally occluded target vessels (TIMI flow 0 or 1);
12. Moderate to Severely calcified target lesion(s);
13. Highly calcified target lesion(s) requiring rotational atherectomy;
14. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
15. Angiographic evidence of thrombus in the target lesion(s);
16. Tryton Stent placement without angioplasty pre-dilatation of the main branch and side branch (i.e., direct stenting is contraindicated)
17. Tryton Stent placement alone, without implantation of a main branch stent
18. An untreated significant (>50%) stenosis proximal or distal in either the side branch or main branch;
19. Impaired runoff in the treatment vessel with diffuse distal disease;
20. Left ventricular ejection fraction (LVEF) 30% (LVEF must be obtained within 6 months prior to the index procedure); -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Interventional; Coronary artery stenting of De novo bifurcation lesions MB & SB	Device: Coronary Artery Stenting; Interventional coronary artery stent placement in De novo bifurcation lesions of the MB & SB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Vessel Failure (TVF)	Composite of cardiac death, target vessel MI (Q and non-Qwave) clinically driven target vessel revascularization	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success	Attainment of <30% residual stenosis within the side branch without device malfunction	48 hrs
Lesion success	Attainment of <30% residual stenosis using any percutaneous method	48 hrs
Procedure success	Lesion success without the occurrence of in-hospital MACE	48 hrs
Death	All-cause and cardiac mortality	1 year
Myocardial infarction (MI)	Q wave and Non-Q wave	1 year
CD-TLR	Clinically driven target lesion revascularization	1 year
CD-TVR	Clinically driven target vessel revascularization	1 year
Stent thrombosis	ARC definition of definite and probable	1 year

Collaborators and Investigators

• Sponsor: Tryton Medical, Inc.
• Investigators: Principal Investigator: Joel Schnieder, MD, Rex Health; Raleigh NC

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Bifurcation lesions
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: P-0161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No