Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY)

NCT ID: NCT01174433

Last Updated: 2012-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-06-30

Brief Summary

To assess the safety and feasibility of the use of the Tryton bifurcation coronary stent system for the treatment of single de novo bifurcation lesions in native coronary arteries.

Detailed Description

Currently available stents were designed for straight lesions, optimised to provide scaffolding (coverage and radial strength) and ease of deliverability. In straight lesions, these stents have been shown to provide superb acute and long-term results. One lesion subset that continues to challenge the interventionalist is bifurcations lesions. A number of different strategies have been employed with standard stents to address bifurcation lesions each of which have significant limitations. Large contemporary registries characterising current stent usage in bifurcating lesions have demonstrated decreased procedural success with increased rates in restenosis and thrombosis (acute, subacute and delayed). The limitations of currently available stents have led groups to develop stents designed specifically to treat bifurcation lesions. The Tryton Side-Branch Stent Stent TM (Tryton Medical, Inc., Newton, MA, USA) is a balloon expandable cobalt chromium stent, designed specifically to treat bifurcation lesions.

The primary objective of this study is to evaluate the safety and feasibility of the use of the Tryton bifurcation coronary stent system for the treatment of single de novo bifurcation lesions in native coronary arteries with reference vessel diameters (RVD) for the proximal main vessel of 2.5 - 5.0 mm, distal main branch of 2.5 - 5.0 mm, and side branch RVD 2.5 - 3.5 mm.

Conditions

Coronary Artery Disease; Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Bifurcation coronary artery disease; Percutaneous coronary intervention; Tryton Stent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tryton bifurcation stent system

Group Type: EXPERIMENTAL

Tryton

Intervention Type: DEVICE

Percutaneous coronary intervention of a bifurcation lesion, with a Tryton bifurcation coronary stent for the side branch and a drug-eluting coronary stent for the main branch

Interventions

Tryton

Percutaneous coronary intervention of a bifurcation lesion, with a Tryton bifurcation coronary stent for the side branch and a drug-eluting coronary stent for the main branch

Intervention Type: DEVICE

Other Intervention Names

Tryton bifurcation stent system

Eligibility Criteria

Inclusion Criteria

• Candidate for percutaneous coronary intervention & emergent coronary artery bypass graft surgery
• Clinical evidence of ischemic heart disease or a positive functional study
• Female patients of childbearing potential has negative pregnancy test within 7 days before trial procedure
• Patient or patient's legal representative provided written informed consent
• Patient agrees to comply with follow-up evaluations

• Target lesion in a single de novo true bifurcation lesion (Medina classification Type 1.1.1; 1.0.1; 0.1.1; 0.0.1) involving a native coronary artery with reference vessel diameter for the proximal main of 2.5 - 5.0 mm, distal main of 2.5 - 5.0 mm, & side branch RVD of 2.5 - 3.5 mm
• Target lesion in main vessel has stenosis of > 50% and <100%
• Syntax score < 32

Exclusion Criteria

• Known hypersensitivity/contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, or sensitivity to contrast media, which can't be adequately pre-medicated
• Platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or a white blood cell (WBC) count <3,000 cells/mm³ within 7 days prior to index procedure
• Serum creatinine level >170 micromol/L within 7 days prior to index procedure
• Evidence of acute MI within 72 hours of intended trial procedure (defined as: QWMI or NQWMI having CK enzymes >2X laboratory upper limit of normal in the presence of a confirming cardiac specific biomarker (Troponin I or T)
• Previous stenting anywhere in target vessel
• Percutaneous coronary intervention (PCI) of non-target vessel within 30 days prior to procedure that results in any MAC(C)E event. If non target vessel stent is implanted within 72 hours prior to index procedure, 2 post procedural serial CK or CK-MB measurements must be below investigational site's upper limit of normal
• PCI of non-target vessel within 24 hours prior to procedure
• Planned PCI of the target vessel within 6 months post-procedure
• During index procedure, target lesion requires treatment with device other than PTCA or cutting balloon prior to stent placement
• Documented left ventricular ejection fraction (LVEF) <30% at most recent evaluation
• History of stroke or transient ischemic attack (TIA) within prior 6 months
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Concurrent medical condition with life expectancy <12 months
• Currently participating in investigational drug or device trial that's not completed the primary endpoint or that clinically interferes with current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.

• Target lesion located in native vessel with saphenous vein graft or left/right internal mammary artery (LIMA/RIMA) bypass
• Target lesion has any of following characteristics:
• Severely calcified
• Evidence of thrombus
• Syntax score ≥33

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mirano's Hospital, Mirano, Italy

UNKNOWN

Sponsor Role: collaborator

San Giacomo Apostolo Hospital, Castelfranco Veneto, Italy

UNKNOWN

Sponsor Role: collaborator

Conegliano Veneto's Hospital, Conegliano Veneto, Italy

UNKNOWN

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Tarantini

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Tarantini, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Padua, Department of Cardiac, Thoracic and Vascular Sciences

Locations

Castelfranco Veneto's Hospital

Castelfranco Veneto, , Italy

Conegliano's Hospital

Conegliano, , Italy

Angel's Hospital

Mestre, , Italy

Mirano's Hospital

Mirano, , Italy

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy

Padua, , Italy

Vicenza's Hospital

Vicenza, , Italy

Countries

Italy

References

Tarantini G, La Vecchia L, Galli M, Favero L, D'Amico G, Buja P, Russo F, Cabianca E, Napodano M, Musumeci G, Franceschini E, Grassi G, Pavei A, Bonmassari R, Cernetti C, Spedicato L, Caprioglio F, Reimers B, Isabella G. Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study. Int J Cardiol. 2013 Oct 15;168(6):5323-8. doi: 10.1016/j.ijcard.2013.08.008. Epub 2013 Aug 16.

Reference Type: DERIVED

PMID: 24007969 (View on PubMed)

Other Identifiers

2040P

Identifier Type: -

Identifier Source: org_study_id