Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
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Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- EndoCore Lab s.r.l.
- Trial code
- NCT06277362
- Record updated
- 24 March 2026
- Original description
The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.Read full original descriptionShow less
"Arterial-Venous Reversal Flow in "No-option" Chronic Limb-threating Ischemia (CLTI) Patients"
The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.
Inclusion: Age ≥18 years; Patient has signed an approved informed consent form; All patients, with non-revascularizable critical lower limb ischemia defined on the basis of 2 previous unsuccessful Percutaneous Transluminal Angioplasty (PTA) attempts or on severe Medial Artery Calcification (MAC)/Small Artery Disease (SAD) stage; Patient with Critical Limb Ischaemia, Rutherford category, 5 (minor tissue loss) or 6 (major tissue loss) with active trophic lesions; Ejection Fraction > 30%.
Exclusion: Ejection Fraction < 30%; Subject no able to perform the follow up or other factors making clinical follow-up difficult; Patients with critical ischaemia of the lower limbs revascularizable by bypass or angioplasty, critical ischaemia characterised by rest pain (Rutherford class ≤ 4).