Endovascular Treatment of Peripheral Artery Disease (PAD)

• Endovascular intervention (Device), also known as Optimed Sinus Superflex 635, Qualimed Talor Minor, Cardionovum Legflow balloon 0.035 + 0.018 + 0.014, Optimed Nylotrack 0.035 + 0.018: Endovascular treatment with stent or balloon according to current practice

Primary outcomes

• Binary restenosis [at 12 months follow-up]: Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio >2.4)

Secondary outcomes

• Device-related complications [up to 12 months follow-up]: Registration of peri- and early/late postoperative complications
• Immediate procedural outcome [during index-procedure]: 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.
• Clinical outcome [at baseline]: Rutherford classification
• Clinical outcome [at 6 weeks follow-up]: Rutherford classification
• Clinical outcome [at 12 months follow-up]: Rutherford classification
• Primary sustained clinical improvement [at 12 months follow-up]: defined as sustained upward shift of ≥ 1 category on Rutherford classification without the need for repeated TLR in surviving patients.
• Secondary sustained clinical improvement [at 12 months follow-up]: defined as sustained upward shift of ≥ 1 category on Rutherford classification including the need for repeated TLR in surviving patients.
• Target lesion revascularization (TLR) [up to 12 months follow-up]: defined as an endovascular or surgical treatment due to a problem arising from the lesion (+1cm proximally and distally to include edge phenomena).
• Mortality [up to 12 months follow-up]: Procedure-related and all-cause mortality.
• Amputation [up to 12 months follow-up]: minor amputation defined as below the ankle and major defined as above the ankle.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Patient must sign the informed consent form prior to the index-procedure.
2. Patient is older than 18 years.
3. Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
4. Patient suffers from mild to intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4-5).
5. Target lesion is an occlusion or diameter stenosis is ≥50% by visual estimate.
6. 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:

1. Patients with Rutherford 0 and 6.
2. Patient is pregnant.
3. Patients with estimated Glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.
4. Patient has an acute thrombus or aneurysm in the target arteries.
5. Patient has a life expectancy of <12 months.
6. Patient has a target lesion that cannot be crossed with a guidewire.
7. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
8. 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.
9. Contraindication for anti-thrombotic therapy (coagulopathy, …).
10. Patient has a known intolerance to anti-thrombotic medication or contrast agents.