Prospective, Single Blind, Rand Controlled Study to Evaluate the Safety & Effectness of Tryton Side Branch Stent Used With DES Treatmt of de Novo Bifurcation Lesions in MB & SB in Native Coronaries (TRYTON)

October 17, 2016 updated by: Tryton Medical, Inc.

TRYTON PIVOTAL IDE Coronary Bifurcation Extended Access Study

The Tryton Side Branch Stent System has been designed to address the procedural difficulty surrounding treatment of bifurcation lesions and to ensure patency of the side branch with similar performance capabilities (e.g., tracking, radiopacity, coverage and radial strength) that are currently available with conventional coronary stents designed for straight (non bifurcation) lesions.

The Tryton Side Branch Stent is intended to treat and maintain patency in the side branch/carina by providing better ostial side branch conformability and is intended for use in conjunction with currently approved balloon-expandable drug-eluding stents for treatment of the main branch.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of drug-eluding stents in the treatment of bifurcation lesions suggests that DES reduces the rate of restenosis int he main branch (5-10%); however, results int he side branch are not optimal. A study of T stenting in true bifurcation lesions showed a restenosis rate int he main branch of approximately 6% using the CYPHER stent. However, the same study demonstrated that the restenosis rate remained high int he side branch (20%) despite stent implantation and when restenosis occurs, it is generally located at the ostium of the side branch. Further, in half the cases where PTCA alone was the intended strategy for the side branch, a side branch stent had to be placed to address sub-optimal procedural results.

These findings are consistent with previous metal stent studies and suggest the best long-term results are obtained when a side branch stent is not placed. This study and others suggest that the outcomes are related to the way the stents sit within in the vessel; and therefore a stent designed specifically for bifurcation lesions will be needed to reduce restenosis rates and improve long-term outcomes.

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York City, New York, United States, 10032
        • Jeffery Moses

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • The patient must be ≥18 and ≤ 90 years of age;
  • Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or have objective evidence of myocardial ischemia);
  • Acceptable candidate for CABG;
  • Intent 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 Medical Ethics Committee (MEC) or Institutional Review Board (IRB).
  • Planned use of one of the following approved and commercially available drug-eluting stents for subject's index procedure: CYPHER®, ENDEAVOR® RESOLUTE, PROMUS® or PROMUS® ELEMENT, XIENCE™ V or XIENCE PRIME.

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;
  • Patient has had a known diagnosis of STEMI acute myocardial infarction (AMI) within 72 hours preceding the index procedure or >72 hours preceding the index procedure and CK and CK-MB have not returned to within normal limits at the time of procedure;
  • Patients with non-STEMI within 7 days prior to index procedure with continued CK-MB elevation;
  • Patients with non-target lesion PCI within 7 days prior to index procedure with continued CK-MB elevation;
  • Impaired renal function (serum creatinine >2.5 mg/dL or 221 μmol/l) or on dialysis;
  • Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3;
  • Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or any other significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
  • Patient has received an organ transplant or is on a waiting list for any organ transplant;
  • Patient has other medical illness (e.g., cancer, known malignancy, or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
  • Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, cobalt-chromium alloy, rapamycin, everolimus, zotarolimus, paclitaxel, and/or contrast sensitivity that cannot be adequately pre-medicated;
  • Patient presents with cardiogenic shock or cardiac arrhythmias that create hemodynamic instability;
  • Patient in whom a surgical or other procedure is planned within the next year which would require discontinuation of dual antiplatelet therapy;
  • Currently participating in another investigational drug or device study or patient inclusion in another investigational drug or device study where the primary endpoint of the study has not been reached.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Angioplasty POBA
Side Branch balloon angioplasty with main branch DES
Device: POBA
Balloon angioplasty
Experimental: Tryton Side Branch Stent
Side Branch treated with Tryton Side Branch Stent with main branch DES
Device: Tryton Side Branch Stent with main branch DES
Tryton Side Branch Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target Vessel Failure (TVF)
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
In-segment % diameter stenosis of the Tryton SB compared to side branch balloon angioplasty
Time Frame: 9 months
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periprocedural MI after PCI, CK-MB elevation with value >3X times the upper range limit within the first 48 hrs after PCI
Time Frame: 48 hours post PCI
Extended Access Registry is the extension of the Prospective multicenter, randomized, controlled study designed to enroll up to 133 subjects treated with the tryton Side Branch Stent with main branch approved DES for treatment of native coronary artery bifurcation disease in lesions >/= 2.5mm RVD
48 hours post PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tryton Medical, Inc.

Investigators

  • Principal Investigator: Martin B. Leon, M.D., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 9, 2010

First Submitted That Met QC Criteria

December 10, 2010

First Posted (Estimate)

December 13, 2010

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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