- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03414515
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
Status
Completed
Conditions
Intervention / Treatment
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:
- 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.
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:
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- BM-PAD-02
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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