Status:
COMPLETED
Endovascular Treatment of Peripheral Artery Disease (PAD)
Lead Sponsor:
Duomed
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 Qualimed Pontos-pp) or balloon angioplasty (Ca...
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 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
- 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.
Key Trial Info
Start Date :
May 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03414515
Start Date
May 2 2018
End Date
December 1 2021
Last Update
September 5 2024
Active Locations (1)
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1
Heilig Hart Ziekenhuis
Mol, Antwerp, Belgium, 2400