Endovascular Treatment of Peripheral Artery Disease (PAD)

Study Overview
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Brief Summary
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The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.

Official Title
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Endovascular Treatment of Peripheral Artery Disease.

Conditions
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Peripheral Arterial Disease, Iliac Artery Disease, Femoropopliteal Occlusive Disease, Below-the-knee Obstruction

Intervention / Treatment
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* Device: Endovascular intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must sign the informed consent form prior to the index-procedure. Patient is older than 18 years. Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime. Patient suffers from mild to intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4-5). Target lesion is an occlusion or diameter stenosis is ≥50% by visual estimate. Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery). Exclusion Criteria: Patients with Rutherford 0 and 6. Patient is pregnant. Patients with estimated Glomerular filtration rate (eGFR) < 30 mL/min/1.73m2. Patient has an acute thrombus or aneurysm in the target arteries. Patient has a life expectancy of <12 months. Patient has a target lesion that cannot be crossed with a guidewire. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability. Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted. Contraindication for anti-thrombotic therapy (coagulopathy, …). Patient has a known intolerance to anti-thrombotic medication or contrast agents.

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 |
| --- | --- |
| Patients with peripheral artery disease<br>located in the common and external iliac artery, the common and superficial femoral artery, the popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery). | Device: Endovascular intervention<br>* Endovascular treatment with stent or balloon according to current practice<br>* Other names: Optimed Nylotrack 0.035 + 0.018;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary restenosis | Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio >2.4) | at 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related complications | Registration of peri- and early/late postoperative complications | up to 12 months follow-up | 
| Immediate procedural outcome | The combination of technical success defined as a successful access and deployment of the device and achievement of a final residual diameter stenosis of <30% of the treated target lesion on the procedural completion angiography and procedural success defined as a combination of technical success and absence of procedural complications. | during index-procedure | 
| Clinical outcome | Rutherford classification | at baseline | 
| Clinical outcome | Rutherford classification | at 6 weeks follow-up | 
| Clinical outcome | Rutherford classification | at 12 months follow-up | 
| Primary sustained clinical improvement | defined as sustained upward shift of ≥ 1 category on Rutherford classification without the need for repeated TLR in surviving patients. | at 12 months follow-up | 
| Secondary sustained clinical improvement | defined as sustained upward shift of ≥ 1 category on Rutherford classification including the need for repeated TLR in surviving patients. | at 12 months follow-up | 
| Target lesion revascularization (TLR) | defined as an endovascular or surgical treatment due to a problem arising from the lesion (+1cm proximally and distally to include edge phenomena). | up to 12 months follow-up | 
| Mortality | Procedure-related and all-cause mortality. | up to 12 months follow-up | 
| Amputation | minor amputation defined as below the ankle and major defined as above the ankle. | up to 12 months follow-up |