Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease
Conditions
Keywords
Bifurcation coronary artery disease, Percutaneous coronary intervention, Tryton Stent
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.
Interventions
DEVICETryton
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
Sponsors
Mirano's Hospital, Mirano, Italy
San Giacomo Apostolo Hospital, Castelfranco Veneto, Italy
Conegliano Veneto's Hospital, Conegliano Veneto, Italy
University of Padova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total volume of contrast used | 24 hours | Total volume of contrast used, in mL |
| Total index PCI procedure time | 24 hours | Total index PCI procedure time, in minutes |
| Angiographic and Procedural success | 30 days (plus or minus 3 days) | 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) |
| Target lesion revascularization (TLR) rate | 9 months | Target lesion revascularization (TLR) rate, at 9 months |
| Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate | 9 months | Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate, at 9 months |
| Target vessel revascularization (TVR) rate | 9 months | Target vessel revascularization (TVR) rate, at 9 months |
Countries
Italy
Outcome results
None listed