NCT06277362 Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
| NCT ID | NCT06277362 |
| Status | Recruiting |
| Phase | — |
| Sponsor | EndoCore Lab s.r.l. |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-01-31 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2020-01-31 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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%
Contact & Investigator
Gabriele Morselli, PharmD
STUDY DIRECTOR
EndocoCore Lab s.r.l.
Frequently Asked Questions
Who can join the NCT06277362 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06277362 currently recruiting?
Yes, NCT06277362 is actively recruiting participants. Contact the research team at g.morselli@endocorelab.org for enrollment information.
Where is the NCT06277362 trial being conducted?
This trial is being conducted at Ancona, Italy, Belluno, Italy, Cesena, Italy, Conegliano, Italy and 5 additional locations.
Who is sponsoring the NCT06277362 clinical trial?
NCT06277362 is sponsored by EndoCore Lab s.r.l.. The principal investigator is Gabriele Morselli, PharmD at EndocoCore Lab s.r.l.. The trial plans to enroll 50 participants.