An observational study in Peripheral Arterial Disease, Critical Limb-Threatening Ischemia and Diabetic Foot, sponsored by EndoCore Lab s.r.l.. Recruiting at 9 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by EndoCore Lab s.r.l. · Observational
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.
Critical lower Limb Threatening Ischemia is the most advanced stage of lower limb arterial disease and is associated with a high risk of mortality and major amputation.Literature data indicate that about 5-10% of patients with peripheral arterial disease have a risk of developing CLTI, therefore the most advanced stage of arterial disease of the lower limbs, within 5 years and have a mortality of 20% at 6 months after diagnosis of CLTI.Despite the continuous improvement of the techniques and materials used in the revascularization of these patients, the data of the Literature show that in about 10-15% of these patients revascularization is impossible or ineffective. This condition is defined as: "no-option" CLTI.Therefore, for patients with "no-option" CLTI an alternative treatment for limb rescue may be considered the use of arterialization of the venous plexus of the foot; that is, to use to bring the arterial flow to the foot a healthy conduit, such as the vein, instead of the diseased artery and no longer usable.
The present study is designed as a multicentre, prospective, single-arm, observational study.
All eligible subjects for undergoing PiPER procedure at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating.
Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data. Once patients are enrolled, their demographics, medical history, disease-relevant conditions, treatment details and outcomes will be collected for up to 24 months from the procedure.
The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.
The revascularization procedure will be performed as per the current clinical practice.
After discharge all patients will attend clinic visits at 30 days (±7 days), 6 months (±14 days),12 months (±30 days), 24 months (±30 days).
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 50 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →EndoCore Lab s.r.l. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects presenting the most advanced stage of lower limb arterial disease, defined as patients with CLTI and no indication for revascularization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 months
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 1
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 months
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 months
A-V fistula flow rate
A-V fistula flow rate
Time frame: 30 days, 3 months, 6 months, 12 months and 24 months
Minor amputation rates
Minor amputation rates defined as a below the ankle amputation
Time frame: 30 days, 3 months, 6 months, 12 months and 24 months
Major amputation rates
Major amputation rates defined as an above the ankle amputation
Time frame: 30 days, 3 months, 6 months, 12 months and 24 months
Re-Treatment rate
Re-Treatment rate defined as need for reintervention
Time frame: 30 days, 3 months, 6 months, 12 months and 24 months
Wound Size
Wound Size defined as wound size reduction index
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
TpcO2
TpcO2 defined as TpcO2 value changes
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
WIFi class
WIFi class and stage changes
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
Freedom from all cause death
Freedom from all cause death
Time frame: 30 days, 3 months, 6 months, 12 months and 24 months
Freedom from procedure-related death
Freedom from procedure-related death
Time frame: 30 days, 3 months
Rutherford class
Rutherford class and stage changes
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
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