RECRUITINGOBSERVATIONAL
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"
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Age ≥18 years
- Patient has signed an approved willing to sign a consent form 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%
Who Should NOT Join This Trial:
- 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%
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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%
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