bifurcation
Conditions
Interventions
The Stentys stent is developed to treat bifurcation lesions. The Stentys stent
itself will be places in the main branch and a standard workhorse stent will be
used in the side branch if required.
Sponsors
Stentys SAS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients from 18-85 years of age. Patients with symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia. Side branch angle from 30 to 70 degrees Main vessel target lesion is located in a native coronary artery. Main vessel diameter 3.0 to 4.5 mm.
Exclusion criteria
Exclusion criteria: Totally occluded vessel Patient not candidated for CABG Left main coronary disease Patient is diabetic Evidence of thrombus Patient pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Endpoint - 'Procedural Success' - Successful deployment of the Stenty stent and creation of side branch opening verified using IVUS - Angiographic Success: | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Parameters: - non-Mace, Serious Adverse Events (SAE) at hospital discharge - MACE and Anginal Status at post procedure and up to 48 months. Angiographic Parameters - Acute IVUS Success - Angiographic restenosis at 6 months and 2 years - Volumetric Late Loss by Ivus and OCT to assess stent coverage at six months and 2 years without OCT - In-stent and vessel segment percentage DS (diameter stenosis) post-procedure. | — |
Countries
Netherlands
Outcome results
None listed