An observational study in Peripheral Arterial Disease, Iliac Artery Disease and Femoropopliteal Occlusive Disease, sponsored by Duomed. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Duomed · Observational
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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 200 is close to the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Duomed is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Endovascular intervention
Endovascular treatment with stent or balloon according to current practice
Also known as: Optimed Sinus Superflex 635, Qualimed Talor Minor, Cardionovum Legflow balloon 0.035 + 0.018 + 0.014, Optimed Nylotrack 0.035 + 0.018
Binary restenosis
Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio \>2.4)
Time frame: at 12 months follow-up
Device-related complications
Registration of peri- and early/late postoperative complications
Time frame: 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.
Time frame: during index-procedure
Clinical outcome
Rutherford classification
Time frame: at baseline
Clinical outcome
Rutherford classification
Time frame: at 6 weeks follow-up
Clinical outcome
Rutherford classification
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: up to 12 months follow-up
Mortality
Procedure-related and all-cause mortality.
Time frame: up to 12 months follow-up
Amputation
minor amputation defined as below the ankle and major defined as above the ankle.
Time frame: up to 12 months follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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