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Endovascular Treatment of Peripheral Artery Disease (PAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03346577
Recruitment Status : Terminated (Termination of collaboration)
First Posted : November 17, 2017
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
be Medical

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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Iliac Artery Disease Below-the-knee Obstruction Femoropopliteal Occlusive Disease Device: stent or balloon

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Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Endovascular Treatment of Peripheral Artery Disease
Actual Study Start Date : May 2, 2018
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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: up to 12 months follow-up ]

    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.

  11. Stent fracture [ Time Frame: up to 12 months follow-up ]
    Only if restenosis occurs, stent fracture will be examined (when Optimed Sinus Superflex 635 stent is used).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346577


Locations
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Belgium
Mariaziekenhuis Noord-Limburg
Overpelt, Limburg, Belgium, 3900
Sponsors and Collaborators
be Medical
Additional Information:

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Responsible Party: be Medical
ClinicalTrials.gov Identifier: NCT03346577    
Other Study ID Numbers: BM-PAD-01
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases