Endovascular Treatment of Peripheral Artery Disease (PAD)

BE Medical

Status: Terminated

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

Treatments: Device: stent or balloon

Study type: Observational

Funder types: Industry

Identifiers

NCT03346577

BM-PAD-01

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 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: 60 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 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) .

Exclusion criteria

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.

Trial design

60 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: stent or balloon