Narrowing vascular disease
Conditions
Interventions
CERAB-technique, as described in the introduction of the study protocol.
Sponsors
Rijnstate Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18 years or older - Provided written informed consent - Clinical necessity for treatment - Eligible anatomy for CERAB without the need for chimney*s - TASC-2 classification as assigned in the study protocol
Exclusion criteria
Exclusion criteria: - Patient is participating in another conflicting clinical study - Patient*s life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Technical success is defined as successful implantation of the CERAB device without occlusion during the first 30-days after implantation and without conversion to open repair - Primary patency at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical: * Patency rates * Target vessel revascularization rate * Conversion to open surgery Clinical: * Freedom from Reinterventions * 30-day morbidity * Incidence of serious adverse events device or procedural related within the 3, 6 and 12 months post intervention period * Overall and reintervention-free survival * Clinical improvement, as measured by the Rutherford category *Patient reported outcomes including general health status, Quality of life and disease specific outcomes | — |
Countries
Netherlands
Outcome results
None listed