Endovascular Treatment of Peripheral Artery Disease (PAD)

December 2, 2021 updated by: Duomed

Endovascular Treatment of Peripheral Artery Disease.

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Antwerp
      • Mol, Antwerp, Belgium, 2400
        • Heilig Hart Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

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).
Endovascular treatment with stent or balloon according to current practice
Other Names:
  • Optimed Sinus Superflex 635
  • Qualimed Talor Minor
  • Cardionovum Legflow balloon 0.035 + 0.018 + 0.014
  • Optimed Nylotrack 0.035 + 0.018

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binary restenosis
Time Frame: 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)
at 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-related complications
Time Frame: up to 12 months follow-up
Registration of peri- and early/late postoperative complications
up to 12 months follow-up
Immediate procedural outcome
Time Frame: 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.
during index-procedure
Clinical outcome
Time Frame: at baseline
Rutherford classification
at baseline
Clinical outcome
Time Frame: at 6 weeks follow-up
Rutherford classification
at 6 weeks follow-up
Clinical outcome
Time Frame: at 12 months follow-up
Rutherford classification
at 12 months follow-up
Primary sustained clinical improvement
Time Frame: 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.
at 12 months follow-up
Secondary sustained clinical improvement
Time Frame: 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.
at 12 months follow-up
Target lesion revascularization (TLR)
Time Frame: 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).
up to 12 months follow-up
Mortality
Time Frame: up to 12 months follow-up
Procedure-related and all-cause mortality.
up to 12 months follow-up
Amputation
Time Frame: up to 12 months follow-up
minor amputation defined as below the ankle and major defined as above the ankle.
up to 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2018

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (Actual)

January 30, 2018

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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