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Trial record 1 of 1 for:    NCT03318796
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Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent (PAS)

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ClinicalTrials.gov Identifier: NCT03318796
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Tryton Medical, Inc.

Tracking Information
First Submitted Date  ICMJE October 2, 2017
First Posted Date  ICMJE October 24, 2017
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE January 22, 2018
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
Target Vessel Failure (TVF) [ Time Frame: 1 year ]
Composite of cardiac death, target vessel MI (Q and non-Qwave) clinically driven target vessel revascularization
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03318796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
  • Device success [ Time Frame: 48 hrs ]
    Attainment of <30% residual stenosis within the side branch without device malfunction
  • Lesion success [ Time Frame: 48 hrs ]
    Attainment of <30% residual stenosis using any percutaneous method
  • Procedure success [ Time Frame: 48 hrs ]
    Lesion success without the occurrence of in-hospital MACE
  • Death [ Time Frame: 1 year ]
    All-cause and cardiac mortality
  • Myocardial infarction (MI) [ Time Frame: 1 year ]
    Q wave and Non-Q wave
  • CD-TLR [ Time Frame: 1 year ]
    Clinically driven target lesion revascularization
  • CD-TVR [ Time Frame: 1 year ]
    Clinically driven target vessel revascularization
  • Stent thrombosis [ Time Frame: 1 year ]
    ARC definition of definite and probable
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
Official Title  ICMJE Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, single arm open label registry
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: Coronary Artery Stenting
Interventional coronary artery stent placement in De novo bifurcation lesions of the MB & SB
Study Arms  ICMJE Interventional
Coronary artery stenting of De novo bifurcation lesions MB & SB
Intervention: Device: Coronary Artery Stenting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2017)
335
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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); -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Doug Ferguson 617-852-9565 dferguson@trytonmedical.com
Contact: Elizabeth Lavelle 508-822-8229 elavelle@trytonmedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03318796
Other Study ID Numbers  ICMJE P-0161
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tryton Medical, Inc.
Study Sponsor  ICMJE Tryton Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joel Schnieder, MD Rex Health; Raleigh NC
PRS Account Tryton Medical, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP