Endovascular Treatment of Peripheral Artery Disease

NCT ID: NCT03346577

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2020-10-01

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

stent or balloon

Intervention Type: DEVICE

Endovascular treatment with stent or balloon according to current practice

Interventions

stent or balloon

Endovascular treatment with stent or balloon according to current practice

Intervention Type: DEVICE

Other Intervention Names

Optimed Sinus Superflex 635 stent; Cardionovum Legflow balloon; Optimed Nylotrack .035 + .018 balloons

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

be Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mariaziekenhuis Noord-Limburg

Overpelt, Limburg, Belgium

Countries

Belgium

Other Identifiers

BM-PAD-01

Identifier Type: -

Identifier Source: org_study_id