Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 2 for:    tryton
Previous Study | Return to List | Next Study

Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries (TRYTON)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Tryton Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Tryton Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01258972
First received: December 9, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease, de Novo Bifurcation Lesions of the Main & Side Branch Within Native Coronaries
Device: Tryton Side Branch Stent with main branch DES

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: TRYTON PIVOTAL IDE Coronary Bifurcation Trial

Further study details as provided by Tryton Medical, Inc.:

Primary Outcome Measures:
  • Target Vessel Failure (TVF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • In-segment % diameter stenosis of the Tryton SB compared to side branch balloon angioplasty [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 133
Study Start Date: December 2010
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Side Branch balloon angioplasty with main branch DES Device: Tryton Side Branch Stent with main branch DES
Tryton Side Branch Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258972

Contacts
Contact: Linda L Laak, BSN 763-233-1692 llaak@trytonmedical.com
Contact: Doug Ferguson 617-852-9565 dferguson@trytonmedical.com

Locations
United States, New York
Jeffery Moses Recruiting
New York City, New York, United States, 10032
Contact: Jeff Moses, MD    212-305-7060    jm2456@columbia.edu   
Sponsors and Collaborators
Tryton Medical, Inc.
Investigators
Principal Investigator: Martin B. Leon, M.D. Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: Tryton Medical, Inc.
ClinicalTrials.gov Identifier: NCT01258972     History of Changes
Other Study ID Numbers: P-0020, Tryton IDE XA
Study First Received: December 9, 2010
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tryton Medical, Inc.:
Bifurcation lesions

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014