Evaluating a new procedure for patients with severe limb ischemia who have no other options
"Arterial-Venous Reversal Flow in "No-option" Chronic Limb-threating Ischemia (CLTI) Patients"
This study is testing a new procedure to see if it can help patients with severe leg circulation problems who have run out of other treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EndoCore Lab s.r.l. Academic / other |
| Locations | 9 sites (Ancona, Ancona and 8 other locations) |
| Trial ID | NCT06277362 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the early safety and effectiveness of a novel procedure called percutaneous deep foot venous arterialization in patients with 'no-option' chronic limb-threatening ischemia (CLTI). The study will enroll patients who have previously undergone unsuccessful revascularization attempts and are at high risk for amputation. By utilizing the venous plexus of the foot as an alternative conduit for arterial flow, the study seeks to provide a potential solution for those with critical lower limb ischemia. Data will be collected on enrolled patients' demographics and medical history to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with non-revascularizable critical limb ischemia and active trophic lesions.
Not a fit: Patients with revascularizable critical ischemia or those unable to comply with follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of amputation and improve limb salvage in patients with no other treatment options.
How similar studies have performed: While this approach is innovative, existing literature indicates that similar techniques have shown promise, but this specific application is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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%
Where this trial is running
Ancona, Ancona and 8 other locations
- Irccs Inrca — Ancona, Ancona, Italy (Recruiting)
- Ospedale San Martino — Belluno, Italy, Italy (Recruiting)
- Ospedale Bufalini — Cesena, Italy, Italy (Recruiting)
- Ospedale di Conegliano - USLL2 — Conegliano, Italy, Italy (Withdrawn)
- Ospedale Cardarelli — Naples, Italy, Italy (Recruiting)
- Arcispedale Santa Maria Nuova — Reggio Emilia, Italy, Italy (Withdrawn)
- Ospedale Santa Chiara — Trento, Italy, Italy (Recruiting)
- Azienda Ospedaliera S. Maria della Misericordia — Perugia, Perugia, Italy (Not_yet_recruiting)
- Ospedale Pederzoli — Peschiera del Garda, Veneto, Italy (Recruiting)
Study contacts
- Principal investigator: Bruno Migliara, MD — Casa di Cura Pederzoli
- Study coordinator: Gabriele Morselli, PharmD
- Email: g.morselli@endocorelab.org
- Phone: +39 3499105666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.