SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Driven Target Lesion Revascularization | The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention. | 1 year after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 ≤50% at the end of the procedure. | At end of procedure | 
| Clinical success | Procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge. | At discharge after procedure | 
| Major Adverse Limb Events (MALE) composite endpoint | Severe limb ischemia leading to an intervention or major vascular amputation (above the ankle). | At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months | 
| Major Cardiac Events Major Cardiac Events | MI, Stroke, Cardiovascular death | At 1, 6, 12, 24, 36,48, 60 months | 
| Death | All-cause, cardiac, device related, procedure related | At 1, 6, 12, 24, 36, 48, 60 months | 
| TLR | Number of Target Lesion Revascularizations | At 1, 6, 12, 24, 36, 48, 60 months | 
| TVR | Number of Target Vessel Revascularizations | At 1, 6, 12, 24, 36, 48, 60 months | 
| Time to first CD-TLR | Time to first Clinically Driven Target Lesion Revascularization | up to 60 months | 
| Target limb revascularization | Number of Target limb revascularizations | At 1, 6, 12, 24, 36, 48, 60 months | 
| Thrombosis at the target site | Number of Thrombosis at the target site | At 1 month | 
| Amputation | Number of Amputations | up to 60 months | 
| Rutherford Classification score | Change in Rutherford Classification score from baseline (Scale from 0 to 6, higher score means worse outcome. | At 6, 12, 24, 36, 48, 60 months | 
| Ankle Brachial Index (ABI) | Change in ankle brachial index (ABI) from baseline | At 6, 12 months only | 
| Pedal pulse | Presence of Pedal pulse | 6, 12 months only | 
| Wound status if applicable | location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score | 6, 12 months only | 
| Kawarada Classification score | Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease | At end of procedure |