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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Angioplasty, Transluminal, Percutaneous Coronary
• Intervention / Treatment: Device: Tryton

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.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Italy
  • Castelfranco Veneto, Italy, 31033
    • Castelfranco Veneto's Hospital
  • Conegliano, Italy, 31015
    • Conegliano's Hospital
  • Mestre, Italy, 30170
    • Angel's Hospital
  • Mirano, Italy, 30035
    • Mirano's Hospital
  • Padua, Italy, 35128
    • Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
  • Vicenza, Italy, 36100
    • Vicenza's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

General 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

Angiographic Inclusion Criteria

• 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:

General 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.

Angiographic Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tryton bifurcation stent system	Device: 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; Other Names: Tryton bifurcation stent system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure	A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure.	30 days (plus or minus 3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic and Procedural success	Acute device success, Technical Success, Clinical Procedural Success, Device malfunctions, Ease-of-Use parameters, Main branch and side branch angiographic endpoints, Main branch and side branch IVUS endpoints (Reference Lumen Area; Reference EEM Area; Lesion Lumen Area; Lesion EEM Area; Maximum Atheroma Thickness; Minimum Atheroma Thickness; Lesion Maximum Lumen Diameter; Lesion Minimum Lumen Diameter and derived Measurements; calcium measurement)	30 days (plus or minus 3 days)
Total volume of contrast used	Total volume of contrast used, in mL	24 hours
Total index PCI procedure time	Total index PCI procedure time, in minutes	24 hours
Target vessel revascularization (TVR) rate	Target vessel revascularization (TVR) rate, at 9 months	9 months
Target lesion revascularization (TLR) rate	Target lesion revascularization (TLR) rate, at 9 months	9 months
Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate	Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate, at 9 months	9 months

Collaborators and Investigators

• Sponsor: University of Padova
• Collaborators: Mirano's Hospital, Mirano, Italy; San Giacomo Apostolo Hospital, Castelfranco Veneto, Italy; Conegliano Veneto's Hospital, Conegliano Veneto, Italy
• Investigators: Principal Investigator: Giuseppe Tarantini, MD, Ph.D., University of Padua, Department of Cardiac, Thoracic and Vascular Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Estimate): July 4, 2012
• Last Update Submitted That Met QC Criteria: July 3, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Bifurcation coronary artery disease; Tryton Stent
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2040P