Endovascular Treatment of Peripheral Artery Disease (PAD)

Duomed

Status: Completed

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

Treatments: Device: Endovascular intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03414515

BM-PAD--02

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Patients with peripheral artery disease

Description:

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).

Treatment:

Device: Endovascular intervention