Actively Recruiting

Age: 18Years +
All Genders
NCT06277362

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

Led by EndoCore Lab s.r.l. · Updated on 2026-03-24

50

Participants Needed

9

Research Sites

461 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Signed an approved informed consent form
  • Non-revascularizable critical lower limb ischemia defined by 2 previous unsuccessful Percutaneous Transluminal Angioplasty (PTA) attempts or severe Medial Artery Calcification (MAC) / Small Artery Disease (SAD) stage
  • Critical Limb Ischemia, Rutherford category 5 (minor tissue loss) or 6 (major tissue loss) with active trophic lesions
  • Ejection Fraction greater than 30%
Not Eligible

You will not qualify if you...

  • Unable to perform follow-up or other factors making clinical follow-up difficult
  • Critical ischemia of the lower limbs that can be revascularized by bypass or angioplasty
  • Critical ischemia characterized by rest pain (Rutherford class 4 or lower)
  • Ejection Fraction less than 30%

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Irccs Inrca

Ancona, Ancona, Italy, 60129

Actively Recruiting

2

Ospedale San Martino

Belluno, Italy, Italy, 32100

Actively Recruiting

3

Ospedale Bufalini

Cesena, Italy, Italy, 47521

Actively Recruiting

4

Ospedale di Conegliano - USLL2

Conegliano, Italy, Italy, 31015

Withdrawn

5

Ospedale Cardarelli

Naples, Italy, Italy, 80131

Actively Recruiting

6

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, Italy, 42122

Withdrawn

7

Ospedale Santa Chiara

Trento, Italy, Italy, 38123

Actively Recruiting

8

Azienda Ospedaliera S. Maria della Misericordia

Perugia, Perugia, Italy, 06156

Not Yet Recruiting

9

Ospedale Pederzoli

Peschiera del Garda, Veneto, Italy, 37019

Actively Recruiting

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Research Team

G

Gabriele Morselli, PharmD

CONTACT

B

Bruno Migliara, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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