Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia

Peripheral Arterial Disease Clinical Trial

— PiPER  

Official title:

"Arterial-Venous Reversal Flow in "No-option" Chronic Limb-threating Ischemia (CLTI) Patients"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277362
• Other study ID #: CLTI012023
• Status: Recruiting
• Start date: January 31, 2020
• Est. completion date: June 2027

Study information

• Verified date: February 2024
• Source: EndoCore Lab s.r.l.
• Contact: Gabriele Morselli, PharmD
• Phone: +39 3499105666
• Email: g.morselli[@]endocorelab.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Diabetic Foot
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Italy	Ospedale San Martino	Belluno
Italy	Ospedale Bufalini	Cesena
Italy	Ospedale di Conegliano - USLL2	Conegliano
Italy	Ospedale Cardarelli	Napoli
Italy	Ospedale Pederzoli	Peschiera Del Garda	Veneto
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Ospedale Santa Chiara	Trento

Sponsors (1)

Lead Sponsor	Collaborator
EndoCore Lab s.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days, 6 months
Secondary	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);	Day 1
Secondary	Primary Patency	Primary patency defined as no occlusion of the arterialized vein tract	30 days, 3 months, 6 months, 12 months and 24 months
Secondary	Secondary Patency	Secondary patency defined as no secondary occlusion of the arterialised vein tract	30 days, 3 months, 6 months, 12 months and 24 months
Secondary	A-V fistula flow rate	A-V fistula flow rate	30 days, 3 months, 6 months, 12 months and 24 months
Secondary	Minor amputation rates	Minor amputation rates defined as a below the ankle amputation	30 days, 3 months, 6 months, 12 months and 24 months
Secondary	Major amputation rates	Major amputation rates defined as an above the ankle amputation	30 days, 3 months, 6 months, 12 months and 24 months
Secondary	Re-Treatment rate	Re-Treatment rate defined as need for reintervention	30 days, 3 months, 6 months, 12 months and 24 months
Secondary	Wound Size	Wound Size defined as wound size reduction index	Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
Secondary	TpcO2	TpcO2 defined as TpcO2 value changes	Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
Secondary	WIFi class	WIFi class and stage changes	Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
Secondary	Freedom from all cause death	Freedom from all cause death	30 days, 3 months, 6 months, 12 months and 24 months
Secondary	Freedom from procedure-related death	Freedom from procedure-related death	30 days, 3 months
Secondary	Rutherford class	Rutherford class and stage changes	Baseline, 30 days, 3 months, 6 months, 12 months and 24 months