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

RECRUITINGSponsored by EndoCore Lab s.r.l.
Actively Recruiting
SponsorEndoCore Lab s.r.l.
Started2020-01-31
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06277362

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

Age: 18 Years+Healthy volunteers accepted
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%

Conditions4

Critical Limb-Threatening IschemiaDiabetesDiabetic FootPeripheral Arterial Disease

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