Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.

Study Overview
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Brief Summary
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Observational registry including patients with peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).

Detailed Description
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The registry includes consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA). Interventional procedure: PTA with Cutting-Balloon (60-120 seconds). PTA with Drug-Coated-Balloon (60 seconds). Technical success is defined as no recoil >30% no dissection >Type B no stenting >30% of lesion length. Follow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE, TLR, TVR, Binary Restenosis).

Official Title
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Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.

Conditions
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Peripheral Artery Disease, Femoropoliteal Stenosis/Occlusion, Cutting-balloon, Drug-coated-balloon

Intervention / Treatment
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* Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: peripheral artery disease (PAD) with femoro-popliteal stenosis >70% or occlusion (vessel diameter 4-6mm) age 18-99 informed consent Exclusion Criteria: proximal / iliacal stenosis stenosis/occlusion of all arteries below the knee

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Femoropopliteal stenosis<br>Consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion. Intervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA. | Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA<br>* Interventional procedure: PTA with Cutting-Balloon (60-120 seconds). PTA with DC-Balloon (60 seconds). Technical success is defined as no recoil >30% no dissection >Type B no stenting >30% of lesion length.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically driven target lesion revascularization (TLR) | clinically driven target lesion revascularization | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinically driven target vessel revascularization (TVR) | TVR | 6 months | 
| Binary restenosis | Peak Systolic velocity (PSV) >2.4 | 6 months | 
| Change in Ankle Brachial Index (ABI) | Change in ankle brachial index from baseline. | 6 months | 
| Change in Rutherford-classification | Change in Rutherford-Classification from Baseline (I-VI) | 6 months | 
| major cardiac adverse events | myocardial infarction, stroke, death, cardiovascular death | 6 months | 
| Amputation |  | 6 months | 
| clinically driven target vessel revascularization (TVR) |  | 12 months | 
| Clinically driven target lesion revascularization (TLR) |  | 12 months | 
| Binary restenosis |  | 12 months | 
| Change in Ankle Brachial Index (ABI) |  | 12 months | 
| Change in Rutherford-classification |  | 12 months | 
| major cardiac adverse events | myocardial infarction, stroke, death, cardiovascular death | 12 months | 
| Amputation |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, femoropoliteal stenosis/occlusion, cutting-balloon, drug-coated-balloon