Clinical trial NCT06277362: Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
Official title: "Arterial-Venous Reversal Flow in "No-option" Chronic Limb-threating Ischemia (CLTI) Patients"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Critical Limb-Threatening Ischemia
Diabetic Foot
Keywords: PAD
DVA
CLTI
Lead sponsor: EndoCore Lab s.r.l.
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects presenting the most advanced stage of lower limb arterial disease, defined as patients with CLTI and no indication for revascularization.

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.

Detailed description: 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).

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%

Primary outcomes:
measure: Safety Composite
timeFrame: 30 days, 6 months
Secondary outcomes:
measure: Procedural Success
timeFrame: Day 1
measure: Primary Patency
timeFrame: 30 days, 3 months, 6 months, 12 months and 24 months
measure: Secondary Patency
timeFrame: 30 days, 3 months, 6 months, 12 months and 24 months
measure: A-V fistula flow rate
timeFrame: 30 days, 3 months, 6 months, 12 months and 24 months
measure: Minor amputation rates
timeFrame: 30 days, 3 months, 6 months, 12 months and 24 months
measure: Major amputation rates
timeFrame: 30 days, 3 months, 6 months, 12 months and 24 months
measure: Re-Treatment rate
timeFrame: 30 days, 3 months, 6 months, 12 months and 24 months
measure: Wound Size
timeFrame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
measure: TpcO2
timeFrame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
measure: WIFi class
timeFrame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
measure: Freedom from all cause death
timeFrame: 30 days, 3 months, 6 months, 12 months and 24 months
measure: Freedom from procedure-related death
timeFrame: 30 days, 3 months
measure: Rutherford class
timeFrame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
Other outcomes:
Locations:
city: Peschiera Del Garda
country: Italy
facility: Ospedale Pederzoli
state: Veneto
city: Belluno
country: Italy
facility: Ospedale San Martino
city: Cesena
country: Italy
facility: Ospedale Bufalini
city: Conegliano
country: Italy
facility: Ospedale di Conegliano - USLL2
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Trento
country: Italy
facility: Ospedale Santa Chiara
Study officials:
affiliation: EndocoCore Lab s.r.l.
name: Gabriele Morselli, PharmD
role: STUDY_DIRECTOR
affiliation: Casa di Cura Pederzoli
name: Bruno Migliara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Casa di Cura Abano Terme
name: Marco Manzi, MD
role: STUDY_CHAIR
References: