Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening
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.
| Condition(s) | Peripheral Arterial Disease, Critical Limb-Threatening Ischemia, Diabetic Foot |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | EndoCore Lab s.r.l. |
| Locations | Ancona, Ancona, Italy; Belluno, Italy, Italy; Cesena, Italy, Italy; Conegliano, Italy, Italy; Naples, Italy, Italy; Reggio Emilia, Italy, Italy (+3 more sites) |
| Start date | 2020-01-31 |
| NCT ID | NCT06277362 |
| Official listing | https://clinicaltrials.gov/study/NCT06277362 |