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

Coronary Atherosclerosis of Native Coronary Artery Clinical Trial

— TRYTON  

Official title:

TRYTON PIVOTAL IDE Coronary Bifurcation Extended Access Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258972
• Other study ID #: P-0020
• Status: Completed
• Phase: N/A
• First received: December 9, 2010
• Last updated: October 17, 2016
• Start date: December 2010
• Est. completion date: October 2016

Study information

• Verified date: April 2016
• Source: Tryton Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: October 2016
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Bifurcation Lesions: de Novo Lesions of the Main and Side Branch of Native Coronary Artery
• Coronary Artery Disease
• Coronary Atherosclerosis of Native Coronary Artery
• Myocardial Ischemia

Intervention

Device:
• Tryton Side Branch Stent with main branch DES
Tryton Side Branch Stent
• POBA
Balloon angioplasty

Locations

Country	Name	City	State
United States	Jeffery Moses	New York City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tryton Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Periprocedural MI after PCI, CK-MB elevation with value >3X times the upper range limit within the first 48 hrs after 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
Primary	Target Vessel Failure (TVF)		9 months
Secondary	In-segment % diameter stenosis of the Tryton SB compared to side branch balloon angioplasty		9 months

External Links

•   Sponsor website