Clinical trial NCT01174433: Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY)
Official title: Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Coronary Artery Disease
Angioplasty, Transluminal, Percutaneous Coronary
Keywords: Bifurcation coronary artery disease
Percutaneous coronary intervention
Tryton Stent
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Mirano's Hospital, Mirano, Italy
name: San Giacomo Apostolo Hospital, Castelfranco Veneto, Italy
name: Conegliano Veneto's Hospital, Conegliano Veneto, Italy
First posted: 2010-08-03
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure
timeFrame: 30 days (plus or minus 3 days)
Secondary outcomes:
measure: Angiographic and Procedural success
timeFrame: 30 days (plus or minus 3 days)
measure: Total volume of contrast used
timeFrame: 24 hours
measure: Total index PCI procedure time
timeFrame: 24 hours
measure: Target vessel revascularization (TVR) rate
timeFrame: 9 months
measure: Target lesion revascularization (TLR) rate
timeFrame: 9 months
measure: Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Castelfranco Veneto
country: Italy
facility: Castelfranco Veneto's Hospital
city: Conegliano
country: Italy
facility: Conegliano's Hospital
city: Mestre
country: Italy
facility: Angel's Hospital
city: Mirano
country: Italy
facility: Mirano's Hospital
city: Padua
country: Italy
facility: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
city: Vicenza
country: Italy
facility: Vicenza's Hospital
Study officials:
affiliation: University of Padua, Department of Cardiac, Thoracic and Vascular Sciences
name: Giuseppe Tarantini, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.