Peripheral Artery Disease
Conditions
Interventions
None listed
Sponsors
M.A. Med Alliance SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject age is >= 18 years 2. Subject is able and willing to provide informed consent 3. Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded from the study: 1. In the opinion of the treating investigator the subject has a life expectancy of less than 12 months 2. In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Device success: Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure. [at end of procedure] - Procedure success: Device success and residual stenosis | — |
Countries
Netherlands
Outcome results
None listed