Endovascular Treatment of Peripheral Artery Disease (PAD)

Completed

• Conditions: Peripheral Arterial Disease; Iliac Artery Disease; Below-the-knee Obstruction; Femoropopliteal Occlusive Disease
• Interventions: Device: Endovascular intervention

• Registration Number: NCT03414515
• Lead Sponsor: Duomed

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-01-30
• Study Start: 2018-05-02
• Status Verified: 2021-12
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with peripheral artery disease	Endovascular intervention	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).

Primary Outcome Measures

Name	Time	Method
Binary restenosis	at 12 months follow-up	Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio \>2.4)

Secondary Outcome Measures

Name	Time	Method
Device-related complications	up to 12 months follow-up	Registration of peri- and early/late postoperative complications
Secondary sustained clinical improvement	at 12 months follow-up	defined as sustained upward shift of ≥ 1 category on Rutherford classification including the need for repeated TLR in surviving patients.
Mortality	up to 12 months follow-up	Procedure-related and all-cause mortality.
Immediate procedural outcome	during index-procedure	The combination of technical success defined as a successful access and deployment of the device and achievement of a final residual diameter stenosis of \<30% of the treated target lesion on the procedural completion angiography and procedural success defined as a combination of technical success and absence of procedural complications.
Clinical outcome	at 12 months follow-up	Rutherford classification
Target lesion revascularization (TLR)	up to 12 months follow-up	defined as an endovascular or surgical treatment due to a problem arising from the lesion (+1cm proximally and distally to include edge phenomena).
Primary sustained clinical improvement	at 12 months follow-up	defined as sustained upward shift of ≥ 1 category on Rutherford classification without the need for repeated TLR in surviving patients.
Amputation	up to 12 months follow-up	minor amputation defined as below the ankle and major defined as above the ankle.

Trial Locations

Locations (1)

Heilig Hart Ziekenhuis; 🇧🇪 Mol, Antwerp, Belgium