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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
241
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
Castelfranco Veneto's Hospital
Castelfranco Veneto, Italy
Conegliano's Hospital
Conegliano, Italy
Angel's Hospital
Mestre, Italy
Mirano's Hospital
Mirano, Italy
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.
Time frame: 30 days (plus or minus 3 days)
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)
Time frame: 30 days (plus or minus 3 days)
Total volume of contrast used
Total volume of contrast used, in mL
Time frame: 24 hours
Total index PCI procedure time
Total index PCI procedure time, in minutes
Time frame: 24 hours
Target vessel revascularization (TVR) rate
Target vessel revascularization (TVR) rate, at 9 months
Time frame: 9 months
Target lesion revascularization (TLR) rate
Target lesion revascularization (TLR) rate, at 9 months
Time frame: 9 months
Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
Padua, Italy
Vicenza's Hospital
Vicenza, Italy
Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate, at 9 months
Time frame: 9 months