Clinical trial NCT03346577: Endovascular Treatment of Peripheral Artery Disease
Official title: Endovascular Treatment of Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Arterial Disease
Iliac Artery Disease
Below-the-knee Obstruction
Femoropopliteal Occlusive Disease
Lead sponsor: be Medical
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 60
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 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 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.

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: up to 12 months follow-up
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
measure: Stent fracture
timeFrame: up to 12 months follow-up
Other outcomes:
Locations:
city: Overpelt
country: Belgium
facility: Mariaziekenhuis Noord-Limburg
state: Limburg
Study officials:
References: