Endovascular Treatment of Peripheral Artery Disease (PAD)

NCT03414515 | Completed

• 1 other identifier: BM-PAD--02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Binary restenosis

  Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio \>2.4)

  at 12 months follow-up

Secondary Outcomes (10)

• Device-related complications

  up to 12 months follow-up

• Immediate procedural outcome

  during index-procedure

• Clinical outcome

  at baseline

• Clinical outcome

  at 6 weeks follow-up

• Clinical outcome

  at 12 months follow-up

Study Arms (1)

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).

Device: Endovascular intervention

Interventions

Endovascular intervention DEVICE

Endovascular treatment with stent or balloon according to current practice

Also known as: Optimed Sinus Superflex 635, Qualimed Talor Minor, Cardionovum Legflow balloon 0.035 + 0.018 + 0.014, Optimed Nylotrack 0.035 + 0.018

Patients with peripheral artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patient must sign the informed consent form prior to the index-procedure.
• Patient is older than 18 years.
• Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
• Patient suffers from mild to intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4-5).
• Target lesion is an occlusion or diameter stenosis is ≥50% by visual estimate.
• 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).

You may not qualify if:

• Patients with Rutherford 0 and 6.
• Patient is pregnant.
• Patients with estimated Glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2.
• Patient has an acute thrombus or aneurysm in the target arteries.
• Patient has a life expectancy of \<12 months.
• Patient has a target lesion that cannot be crossed with a guidewire.
• Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
• 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.
• Contraindication for anti-thrombotic therapy (coagulopathy, …).
• Patient has a known intolerance to anti-thrombotic medication or contrast agents.

Sponsors & Collaborators

• Duomed: lead

Study Sites (1)

Heilig Hart Ziekenhuis

Mol, Antwerp, 2400, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: May 2, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)