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Completed

NCT Number: NCT03414515

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heilig Hart Ziekenhuis

Mol, Antwerp, 2400, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Endovascular intervention

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Device-related complications

    Time frame: up to 12 months follow-up

    Registration of peri- and early/late postoperative complications

  2. 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.

  3. Clinical outcome

    Time frame: at baseline

    Rutherford classification

  4. Clinical outcome

    Time frame: at 6 weeks follow-up

    Rutherford classification

  5. Clinical outcome

    Time frame: at 12 months follow-up

    Rutherford classification

  6. 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.

  7. 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.

  8. 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).

  9. Mortality

    Time frame: up to 12 months follow-up

    Procedure-related and all-cause mortality.

  10. Amputation

    Time frame: up to 12 months follow-up

    minor amputation defined as below the ankle and major defined as above the ankle.

Sponsors and collaborators

Lead sponsor

Duomed

Industry

Registry information

Official study title

Endovascular Treatment of Peripheral Artery Disease.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2018
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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