Critical Limb-Threatening Ischemia, Diabetic Foot, Peripheral Arterial Disease
Conditions
Keywords
PAD, DVA, CLTI
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).
Interventions
None listed
Sponsors
EndoCore Lab s.r.l.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Composite | 30 days, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | Day 1 | 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); |
| Primary Patency | 30 days, 3 months, 6 months, 12 months and 24 months | Primary patency defined as no occlusion of the arterialized vein tract |
| Secondary Patency | 30 days, 3 months, 6 months, 12 months and 24 months | Secondary patency defined as no secondary occlusion of the arterialised vein tract |
| A-V fistula flow rate | 30 days, 3 months, 6 months, 12 months and 24 months | A-V fistula flow rate |
| Minor amputation rates | 30 days, 3 months, 6 months, 12 months and 24 months | Minor amputation rates defined as a below the ankle amputation |
| Major amputation rates | 30 days, 3 months, 6 months, 12 months and 24 months | Major amputation rates defined as an above the ankle amputation |
| Re-Treatment rate | 30 days, 3 months, 6 months, 12 months and 24 months | Re-Treatment rate defined as need for reintervention |
| Wound Size | Baseline, 30 days, 3 months, 6 months, 12 months and 24 months | Wound Size defined as wound size reduction index |
| TpcO2 | Baseline, 30 days, 3 months, 6 months, 12 months and 24 months | TpcO2 defined as TpcO2 value changes |
| WIFi class | Baseline, 30 days, 3 months, 6 months, 12 months and 24 months | WIFi class and stage changes |
| Freedom from all cause death | 30 days, 3 months, 6 months, 12 months and 24 months | Freedom from all cause death |
| Freedom from procedure-related death | 30 days, 3 months | Freedom from procedure-related death |
| Rutherford class | Baseline, 30 days, 3 months, 6 months, 12 months and 24 months | Rutherford class and stage changes |
Countries
Italy
Contacts
CONTACTGabriele Morselli, PharmD
CONTACTBruno Migliara, MD
STUDY_DIRECTORGabriele Morselli, PharmD
EndocoCore Lab s.r.l.
PRINCIPAL_INVESTIGATORBruno Migliara, MD
Casa di Cura Pederzoli
STUDY_CHAIRMarco Manzi, MD
Casa di Cura Abano Terme
Outcome results
None listed