RecruitingNCT06277362

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

"Arterial-Venous Reversal Flow in "No-option" Chronic Limb-threating Ischemia (CLTI) Patients"

Sponsor

EndoCore Lab s.r.l.

Enrollment

50 participants

Start Date

Jan 31, 2020

Study Type

OBSERVATIONAL

Conditions

Peripheral Arterial Disease Diabetic Foot Critical Limb-Threatening Ischemia

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria3

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)
Ejection Fraction < 30%

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Locations(9)

Irccs Inrca

Ancona, Ancona, Italy

Ospedale San Martino

Belluno, Italy, Italy

Ospedale Bufalini

Cesena, Italy, Italy

Ospedale di Conegliano - USLL2

Conegliano, Italy, Italy

Ospedale Cardarelli

Naples, Italy, Italy

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, Italy

Ospedale Santa Chiara

Trento, Italy, Italy

Azienda Ospedaliera S. Maria della Misericordia

Perugia, Perugia, Italy

Ospedale Pederzoli

Peschiera del Garda, Veneto, Italy

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NCT06277362

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