Peripheral Artery Disease
Conditions
Brief summary
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
Detailed description
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB). This study will capture data from the use of the SELUTION SLR according to its approved labelling. Each indication for use will have a specific data sets in addition to generic data sets that are common across all indications. Patients will be followed for 5 years post-procedure to obtain safety and efficacy data. A health economic analysis will be made comparing data between countries within the study and to published data for existing treatment options. Generic and disease specific Patient Reported Outcome Measures (PROMs) will be used to measure the impact of the intervention on the overall health status of patients. Imaging data collection for patients whose standard of care includes imaging follow-up will be captured and analysed. Data will be collected from any subject who receives a CE marked device for treatment of a peripheral (i.e. non-cardiovascular) vascular lesion. Data analysis will be stratified by lesion location.
Interventions
DEVICESELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)
This study will capture data from the use of the SELUTION SLR according to its approved labelling.
Sponsors
M.A. Med Alliance S.A.
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
* Subject age is ≥ 18 years * Subject is able and willing to provide informed consent * Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use.
Exclusion criteria
* In the opinion of the treating investigator the subject has a life expectancy of less than 12 months * 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 | Description |
|---|---|---|
| Clinically Driven Target Lesion Revascularization | 1 year after treatment | The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success | At end of procedure | Device success and residual stenosis ≤50% at the end of the procedure. |
| Clinical success | At discharge after procedure | Procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge. |
| Major Adverse Limb Events (MALE) composite endpoint | At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months | Severe limb ischemia leading to an intervention or major vascular amputation (above the ankle). |
| Major Cardiac Events Major Cardiac Events | At 1, 6, 12, 24, 36,48, 60 months | MI, Stroke, Cardiovascular death |
| Death | At 1, 6, 12, 24, 36, 48, 60 months | All-cause, cardiac, device related, procedure related |
| TLR | At 1, 6, 12, 24, 36, 48, 60 months | Number of Target Lesion Revascularizations |
| TVR | At 1, 6, 12, 24, 36, 48, 60 months | Number of Target Vessel Revascularizations |
| Time to first CD-TLR | up to 60 months | Time to first Clinically Driven Target Lesion Revascularization |
| Device Success | At end of procedure | Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure. |
| Thrombosis at the target site | At 1 month | Number of Thrombosis at the target site |
| Amputation | up to 60 months | Number of Amputations |
| Rutherford Classification score | At 6, 12, 24, 36, 48, 60 months | Change in Rutherford Classification score from baseline (Scale from 0 to 6, higher score means worse outcome. |
| Ankle Brachial Index (ABI) | At 6, 12 months only | Change in ankle brachial index (ABI) from baseline |
| Pedal pulse | 6, 12 months only | Presence of Pedal pulse |
| Wound status if applicable | 6, 12 months only | location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score |
| Kawarada Classification score | At end of procedure | Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease |
| Target limb revascularization | At 1, 6, 12, 24, 36, 48, 60 months | Number of Target limb revascularizations |
Countries
Argentina, Germany, Greece, Netherlands, Singapore, Slovakia, Switzerland, United Kingdom
Outcome results
None listed