Endovascular Treatment of Peripheral Artery Disease

NCT03346577 | Terminated

• 1 other identifier: BM-PAD-01
• Study Type: observational
• Target: 60
• 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 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; Below-the-knee Obstruction; Femoropopliteal Occlusive Disease

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 (11)

• Device-related complications

  up to 12 months follow-up

• Immediate procedural outcome

  up to 12 months follow-up

• 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: stent or balloon

Interventions

stent or balloon DEVICE

Endovascular treatment with stent or balloon according to current practice

Also known as: Optimed Sinus Superflex 635 stent, Cardionovum Legflow balloon, Optimed Nylotrack .035 + .018 balloons

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 intermittent claudication (Rutherford 2-3) or critical limb ischemia (Rutherford 4-5).
• Target lesion is an occlusion or diameter stenosis is ≥70% 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, 1 and 6.
• Patient is pregnant.
• Patients with serum creatinine \>2.0 mg/dL or renal dialysis.
• Patient has an acute thrombus or aneurysm in the target arteries.
• Patient has a life expectancy of \<12 months.
• Patient with bypass that involves the target arteries.
• 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

• be Medical: lead

Study Sites (1)

Mariaziekenhuis Noord-Limburg

Overpelt, Limburg, 3900, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 17, 2017
• Study Start: May 2, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

BE (1)