Status:
TERMINATED
Endovascular Treatment of Peripheral Artery Disease
Lead Sponsor:
be Medical
Conditions:
Peripheral Arterial Disease
Iliac Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or O...
Eligibility Criteria
Inclusion
- 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 intermittent claudication (Rutherford 2-3) or critical limb ischemia (Rutherford 4-5).
- Target lesion is an occlusion or diameter stenosis is ≥70% 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
- Patients with Rutherford 0, 1 and 6.
- Patient is pregnant.
- Patients with serum creatinine \>2.0 mg/dL or renal dialysis.
- Patient has an acute thrombus or aneurysm in the target arteries.
- Patient has a life expectancy of \<12 months.
- Patient with bypass that involves the target arteries.
- 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.
Key Trial Info
Start Date :
May 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03346577
Start Date
May 2 2018
End Date
October 1 2020
Last Update
January 14 2021
Active Locations (1)
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1
Mariaziekenhuis Noord-Limburg
Overpelt, Limburg, Belgium, 3900