BIOLUX P-III SPAIN All-Comers Registry

Study Overview
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Brief Summary
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The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily clinical practice

Official Title
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BIOTRONIK - A Prospective, National, Multi-centre, Post-market Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Long Femoropopliteal Artery Lesions - III SPAIN

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 Subject classified as Rutherford class 4, 5 or 6 TASC C or D lesion(s) in the femoropopliteal artery Lesion length > 15 cm suitable for endovascular treatment treated with or scheduled to be treated with the Passeo-18 Lux drug releasing balloon Exclusion Criteria: Life expectancy ≤ 1 year 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. Rutherford class <4 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 endovascular procedure is conducted as per the local standard practice and device instruction for use|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (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 (TLR) |  | 6 months | 
| Freedom from clinically-driven target vessel revascularization (TVR) |  | 6 and 12 months | 
| Primary Patency | defined as 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 months | 
| Freedom from MAE | Composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven TLR | 12 months | 
| Change in mean Ankle Brachial Index (ABI) | Thigh or toe brachial index (TBI) may be used / performed if ABI is inadequate | 6 and 12 months | 
| Improvement in Rutherford classification compared to the pre-procedure Rutherford classification |  | 6 and 12 months | 
| Amputation-free survival (AFS) including major, minor and overall AFS |  | 6 and 12 months | 
| Pain score compared to the pre-procedure score |  | 6 and 12 months | 
| Walking Impairment Questionnaire compared to the pre-procedure score |  | 6 and 12 months | 
| Device success | Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB. | Immediately upon 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 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 |