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Taking people in ItalyNo phase

Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia

Key facts

Where
Ancona, Belluno, Cesena, Conegliano, Naples, Perugia, Peschiera del Garda, Reggio Emilia, and Trento, ItalySee the 9 sites

Where in Italy

  • Irccs InrcaAncona, ItalyContact: Enrico Paci, MDTaking people
  • Ospedale San MartinoBelluno, ItalyContact: Sandro Irsara, MDTaking people
  • Ospedale BufaliniCesena, ItalyContact: Gabriele Testi, MDTaking people
  • Ospedale di Conegliano - USLL2Conegliano, ItalyContact: Gabriele Morselli, PharmDNo longer taking part
  • Ospedale CardarelliNaples, ItalyContact: Gianluca Cangiano, MDTaking people
  • Azienda Ospedaliera S. Maria Della MisericordiaPerugia, ItalyContact: Massimo Lenti, MDNot yet recruiting
  • Ospedale PederzoliPeschiera del Garda, ItalyContact: Bruno Migliara, MDTaking people
  • Arcispedale Santa Maria NuovaReggio Emilia, ItalyContact: Gabriele Morselli, PharmDNo longer taking part
  • Ospedale Santa ChiaraTrento, ItalyContact: Stefano Bonvini, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

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).

ClinicalTrials.gov NCT06277362