Lead Sponsor

be Medical

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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 intermittent claudication (Rutherford 2-3) or critical limb ischemia (Rutherford 4-5).
•5. Target lesion is an occlusion or diameter stenosis is ≥70% 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) .

•1. Patients with Rutherford 0, 1 and 6.
•2. Patient is pregnant.
•3. Patients with serum creatinine \>2.0 mg/dL or renal dialysis.
•4. Patient has an acute thrombus or aneurysm in the target arteries.
•5. Patient has a life expectancy of \<12 months.
•6. Patient with bypass that involves the target arteries.
•7. Patient has a target lesion that cannot be crossed with a guidewire.
•8. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
•9. 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.
•10. Contraindication for anti-thrombotic therapy (coagulopathy, …).
•11. Patient has a known intolerance to anti-thrombotic medication or contrast agents.