BIOLUX P-III BENELUX All-Comers Registry

Study Overview
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Brief Summary
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The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries

Official Title
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BIOTRONIK - A Prospective, International, Multi-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Popliteal Arteries - III BENELUX

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Passeo-18 Lux DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years or minimum age as required by local regulations Subject must be willing to sign a Patient Data Release Form (PDRF) or Patient Informed Consent (PIC) where applicable Lesion(s) in the popliteal arteries suitable for endovascular treatment, treated with or scheduled to be treated with the Passeo-18 Lux drug coated balloon. Isolated popliteal artery lesion: at least 2 cm of healthy segment between lesion(s) in the popliteal artery and lesion(s) in distal superficial femoral artery Inflow free from flow-limiting lesion. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion(s) have been treated successfully before or during the index procedure, with a maximum residual stenosis of 30% per visual assessment At least one native artery with direct outflow artery to the foot Rutherford classification 2-5 Patient with bypass surgery in the same limb can be enrolled if there is at least 2 cm healthy segment between popliteal artery and anastomosis Exclusion Criteria: Life expectancy ≤ 1 year Rutherford classification 6 Lesion involving the superficial femoral artery (arterial intersection with the femur in an anteroposterior view) or extending in infra-popliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk) Aneurysm at the level of the popliteal artery Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations) Intraprocedural decision not to proceed with the Passeo18 Lux DCB for any reason not related to the device (for instance blood flow limiting dissection after predilatation) Subject is currently participating in another investigational drug or device study that has not reached its primary endpoint yet Subject is pregnant or planning to become pregnant during the course of the study

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Passeo-18 Lux DCB|The decision to treat the patient with Passeo-18 DCB is at the investigator discretion. The endovascular procedure is performed as per standard of care and device Instructions For Use (IFU)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Major Adverse Events (MAE) | Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) | 6 months | 
| Freedom from clinically driven target lesion revascularization (cd-TLR) | Any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from clinically-driven target lesion revascularization (cd-TLR) |  | 6 and 24 months | 
| Freedom from clinically-driven target vessel revascularization (TVR) |  | 6, 12 and 24 months | 
| Primary patency | freedom from >50% restenosis in the target lesion as indicated by a duplex ultrasound peak systolic velocity ratio (PSVR) >2.5 or by visual assessment of an angiogram with no clinically driven re-intervention | 12 and 24 months | 
| Freedom from Major Adverse Events (MAE) | Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) | 12 and 24 months | 
| Change in mean Ankle Brachial Index (ABI) | compared to the pre-procedure | 6, 12 and 24 months | 
| Improvement in Rutherford classification | compared to the pre-procedure Rutherford classification | 6, 12 and 24 months | 
| Amputation-free survival (AFS) | including major, minor and overall AFS | 6, 12 and 24 months | 
| Pain score | compared to the pre-procedure score. | 6, 12 and 24 months | 
| Walking Impairment Questionnaire | compared to the pre-procedure score. | 6, 12 and 24 months | 
| Device success | Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB | immediately upon index procedure | 
| Technical success | Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation | immediately upon index procedure | 
| Procedural success | Procedural success is technical and device success without the occurrence of any MAE (as defined in the protocol) during the hospital stay | immediately upon discharge |