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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03318796
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : February 26, 2019
Information provided by (Responsible Party):
Tryton Medical, Inc.

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Coronary Artery Stenting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 335 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single arm open label registry
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2022

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Target Vessel Failure (TVF) [ Time Frame: 1 year ]
    Composite of cardiac death, target vessel MI (Q and non-Qwave) clinically driven target vessel revascularization

Secondary Outcome Measures :
  1. Device success [ Time Frame: 48 hrs ]
    Attainment of <30% residual stenosis within the side branch without device malfunction

  2. Lesion success [ Time Frame: 48 hrs ]
    Attainment of <30% residual stenosis using any percutaneous method

  3. Procedure success [ Time Frame: 48 hrs ]
    Lesion success without the occurrence of in-hospital MACE

  4. Death [ Time Frame: 1 year ]
    All-cause and cardiac mortality

  5. Myocardial infarction (MI) [ Time Frame: 1 year ]
    Q wave and Non-Q wave

  6. CD-TLR [ Time Frame: 1 year ]
    Clinically driven target lesion revascularization

  7. CD-TVR [ Time Frame: 1 year ]
    Clinically driven target vessel revascularization

  8. Stent thrombosis [ Time Frame: 1 year ]
    ARC definition of definite and probable

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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 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); -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03318796

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Contact: Doug Ferguson 617-852-9565
Contact: Elizabeth Lavelle 508-822-8229

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United States, North Carolina
NC Heart and Vascular Research/UNC REX Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Joel Schneider, M.D.    919-787-5380   
Sponsors and Collaborators
Tryton Medical, Inc.
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Principal Investigator: Joel Schnieder, MD Rex Health; Raleigh NC

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Responsible Party: Tryton Medical, Inc. Identifier: NCT03318796    
Other Study ID Numbers: P-0161
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Tryton Medical, Inc.:
Bifurcation lesions
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases