Heilig Hart Ziekenhuis
Mol, Antwerp, 2400, Belgium
NCT Number: NCT03414515
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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Notify Me18 year and older
All sexes
Observational
Mol, Antwerp, 2400, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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)
Time frame: up to 12 months follow-up
Registration of peri- and early/late postoperative complications
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.
Time frame: at baseline
Rutherford classification
Time frame: at 6 weeks follow-up
Rutherford classification
Time frame: at 12 months follow-up
Rutherford classification
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.
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.
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).
Time frame: up to 12 months follow-up
Procedure-related and all-cause mortality.
Time frame: up to 12 months follow-up
minor amputation defined as below the ankle and major defined as above the ankle.
Duomed
Industry
Endovascular Treatment of Peripheral Artery Disease.
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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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