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

NCT01258972 | Completed DMC

• 1 other identifier: P-0020
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Atherosclerosis of Native Coronary Artery; Bifurcation Lesions: de Novo Lesions of the Main and Side Branch of Native Coronary Artery

Keywords

Bifurcation lesions

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure (TVF)

  9 months

Secondary Outcomes (1)

• In-segment % diameter stenosis of the Tryton SB compared to side branch balloon angioplasty

  9 months

Other Outcomes (1)

• Periprocedural MI after PCI, CK-MB elevation with value >3X times the upper range limit within the first 48 hrs after PCI

  48 hours post PCI

Study Arms (2)

Angioplasty POBA

ACTIVE COMPARATOR

Side Branch balloon angioplasty with main branch DES

Device: POBA

Tryton Side Branch Stent

EXPERIMENTAL

Side Branch treated with Tryton Side Branch Stent with main branch DES

Device: Tryton Side Branch Stent with main branch DES

Interventions

Tryton Side Branch Stent with main branch DES DEVICE

Tryton Side Branch Stent

Tryton Side Branch Stent

POBA DEVICE

Balloon angioplasty

Angioplasty POBA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tryton Medical, Inc.: lead

Study Sites (1)

Jeffery Moses

New York, New York, 10032, United States

Location

Related Publications (4)

• Grundeken MJ, Collet C, Ishibashi Y, Genereux P, Muramatsu T, LaSalle L, Kaplan AV, Wykrzykowska JJ, Morel MA, Tijssen JG, de Winter RJ, Onuma Y, Leon MB, Serruys PW. Visual estimation versus different quantitative coronary angiography methods to assess lesion severity in bifurcation lesions. Catheter Cardiovasc Interv. 2018 Jun;91(7):1263-1270. doi: 10.1002/ccd.27243. Epub 2017 Aug 24.

  PMID: 28836339 DERIVED

• Muramatsu T, Grundeken MJ, Ishibashi Y, Nakatani S, Girasis C, Campos CM, Morel MA, Jonker H, de Winter RJ, Wykrzykowska JJ, Garcia-Garcia HM, Leon MB, Serruys PW, Onuma Y; TRYTON Pivotal IDE Coronary Bifurcation Trial Investigators. Comparison between two- and three-dimensional quantitative coronary angiography bifurcation analyses for the assessment of bifurcation lesions: A subanalysis of the TRYTON pivotal IDE coronary bifurcation trial. Catheter Cardiovasc Interv. 2015 Sep;86(3):E140-9. doi: 10.1002/ccd.25925. Epub 2015 Apr 24.

  PMID: 25914327 DERIVED

• Grundeken MJ, Ishibashi Y, Genereux P, LaSalle L, Iqbal J, Wykrzykowska JJ, Morel MA, Tijssen JG, de Winter RJ, Girasis C, Garcia-Garcia HM, Onuma Y, Leon MB, Serruys PW. Inter-core lab variability in analyzing quantitative coronary angiography for bifurcation lesions: a post-hoc analysis of a randomized trial. JACC Cardiovasc Interv. 2015 Feb;8(2):305-314. doi: 10.1016/j.jcin.2014.12.002.

  PMID: 25700754 DERIVED

• Genereux P, Kumsars I, Lesiak M, Kini A, Fontos G, Slagboom T, Ungi I, Metzger DC, Wykrzykowska JJ, Stella PR, Bartorelli AL, Fearon WF, Lefevre T, Feldman RL, LaSalle L, Francese DP, Onuma Y, Grundeken MJ, Garcia-Garcia HM, Laak LL, Cutlip DE, Kaplan AV, Serruys PW, Leon MB. A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions. J Am Coll Cardiol. 2015 Feb 17;65(6):533-43. doi: 10.1016/j.jacc.2014.11.031.

  PMID: 25677311 DERIVED

Related Links

• Sponsor website

Study Officials

• Martin B. Leon, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 13, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: October 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-04

Locations

US (1)