Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEndoCore Lab s.r.l.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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%
Trial population
Subjects presenting the most advanced stage of lower limb arterial disease, defined as patients with CLTI and no indication for revascularization.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Safety Composite
Composite of amputation free survival, defined as the rate of limb salvage (freedom from major amputation) and survival (freedom from all causes of death) of the percutaneous deep foot venous arterialization procedure.
Time frame
30 days, 6 monthsSecondary outcomes
1
Procedural Success
Procedural success (defined as completion of the procedure by percutaneous route with achievement of arterial flow in the venous plexus of the foot at the end, as angiographically assessed);
Time frame
Day 12
Primary Patency
Primary patency defined as no occlusion of the arterialized vein tract
Time frame
30 days, 3 months, 6 months, 12 months and 24 months3
Secondary Patency
Secondary patency defined as no secondary occlusion of the arterialised vein tract
Time frame
30 days, 3 months, 6 months, 12 months and 24 months4
A-V fistula flow rate
A-V fistula flow rate
Time frame
30 days, 3 months, 6 months, 12 months and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov