Clinical trial NCT03414515: Endovascular Treatment of Peripheral Artery Disease (PAD)
Official title: Endovascular Treatment of Peripheral Artery Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Iliac Artery Disease
Femoropopliteal Occlusive Disease
Below-the-knee Obstruction
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2018-01-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peripheral artery disease, 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).

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 (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.


Eligibility criteria: 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.

Primary outcomes:
measure: Binary restenosis
timeFrame: at 12 months follow-up
Secondary outcomes:
measure: Device-related complications
timeFrame: up to 12 months follow-up
measure: Immediate procedural outcome
timeFrame: during index-procedure
measure: Clinical outcome
timeFrame: at baseline
measure: Clinical outcome
timeFrame: at 6 weeks follow-up
measure: Clinical outcome
timeFrame: at 12 months follow-up
measure: Primary sustained clinical improvement
timeFrame: at 12 months follow-up
measure: Secondary sustained clinical improvement
timeFrame: at 12 months follow-up
measure: Target lesion revascularization (TLR)
timeFrame: up to 12 months follow-up
measure: Mortality
timeFrame: up to 12 months follow-up
measure: Amputation
timeFrame: up to 12 months follow-up
Other outcomes:
Locations:
city: Mol
country: Belgium
facility: Heilig Hart Ziekenhuis
state: Antwerp
Study officials:
References: