Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease, Critical Limb-Threatening Ischemia, Diabetic Foot. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
"Arterial-Venous Reversal Flow in "No-option" Chronic Limb-threating Ischemia (CLTI) Patients"
Overview
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).
Primary outcome measures
- Safety Composite [Time frame: 30 days, 6 months]
Secondary outcome measures (12)
- Procedural Success [Time frame: Day 1]
- Primary Patency [Time frame: 30 days, 3 months, 6 months, 12 months and 24 months]
- Secondary Patency [Time frame: 30 days, 3 months, 6 months, 12 months and 24 months]
- A-V fistula flow rate [Time frame: 30 days, 3 months, 6 months, 12 months and 24 months]
- Minor amputation rates [Time frame: 30 days, 3 months, 6 months, 12 months and 24 months]
- Major amputation rates [Time frame: 30 days, 3 months, 6 months, 12 months and 24 months]
- Re-Treatment rate [Time frame: 30 days, 3 months, 6 months, 12 months and 24 months]
- Wound Size [Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months]
- TpcO2 [Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months]
- WIFi class [Time frame: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months]
- Freedom from all cause death [Time frame: 30 days, 3 months, 6 months, 12 months and 24 months]
- Freedom from procedure-related death [Time frame: 30 days, 3 months]
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%
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 9 centers
- Irccs Inrca — Ancona
- Ospedale San Martino — Belluno
- Ospedale Bufalini — Cesena
- Ospedale di Conegliano - USLL2 — Conegliano
- Ospedale Cardarelli — Naples
- Arcispedale Santa Maria Nuova — Reggio Emilia
- Ospedale Santa Chiara — Trento
- Azienda Ospedaliera S. Maria della Misericordia — Perugia
- … and 1 more center
Identifiers
NCT: NCT06277362 · CLTI012023