Endovascular Treatment of Peripheral Artery Disease (PAD)

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Arterial Disease; Iliac Artery Disease; Femoropopliteal Occlusive Disease; Below-the-knee Obstruction
• Intervention / Treatment: Device: stent or balloon

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Overpelt, Limburg, Belgium, 3900
      • Mariaziekenhuis Noord-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Endovascular treatment with stent or balloon according to current practice; Other Names: Optimed Sinus Superflex 635 stent; Cardionovum Legflow balloon; Optimed Nylotrack .035 + .018 balloons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related complications	Registration of peri- and early/late postoperative complications	up to 12 months follow-up
Clinical outcome	Rutherford classification	at baseline
Clinical outcome	Rutherford classification	at 6 weeks follow-up
Clinical outcome	Rutherford classification	at 12 months follow-up
Primary sustained clinical improvement	defined as sustained upward shift of ≥ 1 category on Rutherford classification without the need for repeated TLR in surviving patients.	at 12 months follow-up
Secondary sustained clinical improvement	defined as sustained upward shift of ≥ 1 category on Rutherford classification including the need for repeated TLR in surviving patients.	at 12 months follow-up
Target lesion revascularization (TLR)	defined as an endovascular or surgical treatment due to a problem arising from the lesion (+1cm proximally and distally to include edge phenomena).	up to 12 months follow-up
Mortality	Procedure-related and all-cause mortality.	up to 12 months follow-up
Amputation	minor amputation defined as below the ankle and major defined as above the ankle.	up to 12 months follow-up
Immediate procedural outcome	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.	up to 12 months follow-up
Stent fracture	Only if restenosis occurs, stent fracture will be examined (when Optimed Sinus Superflex 635 stent is used).	up to 12 months follow-up

Collaborators and Investigators

• Sponsor: be Medical

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2018
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (ACTUAL): November 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: BM-PAD-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No