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Pressure Wire Guidance for Infrapopliteal Artery Interventions

RecruitingNAAges 19 Years - anyAllYonsei University
NCT06879561 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

"• A prospective, single-center randomized controlled comparison trial. * A total of 100 patients with symptoms of chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be included if they meet the inclusion criteria and do not meet any exclusion criteria. * Patients will be randomized in a 1:1 open-label manner either to the pressure wire-guided group or the angiography-guided group. * Patients will be treated with balloon angioplasty for anetrior tibial artery or posterior tibial artery lesions. * In the angiography-guided group, balloon angioplasty will be performed to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis \>50% or flow-limiting dissection. * In the Pressure Wire-guided goru

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient with chronic limb threatening ischemia (Rutherford 5) * Anterior tibial artery or posterior tibial artery lesions ≥ 10 cm Age ≥19 years Exclusion Criteria: * Acute limb ischemia * Contraindication to antiplatelet or anticoagulation agents: 1. Thrombocytopenia (platelet \<100,000/uL) 2. Previous cerebral hemorrhage, GI bleeding, other reasons for increased bleeding risk within 6 months * Pregnant women or women with potential childbearing * Life expectancy \< 1 year
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What it tests

  • Angiography-guided angioplasty
  • Pressure wire-guided angioplasty
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Where

1 site
Division of Cardiology, Severance Cardiovascular hospital Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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