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

Last updated: March 23, 2026
Sponsor: EndoCore Lab s.r.l.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Claudication

Circulation Disorders

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT06277362
CLTI012023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Patient has signed an approved informed consent form

  • All patients, with non-revascularizable critical lower limb ischemia defined on thebasis 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

Exclusion Criteria:

  • Subject no able to perform the follow up or other factors making clinical follow-updifficult

  • Patients with critical ischaemia of the lower limbs revascularizable by bypass orangioplasty, critical ischaemia characterised by rest pain (Rutherford class ≤ 4)

  • Ejection Fraction < 30%

Study Design

Total Participants: 50
Study Start date:
January 31, 2020
Estimated Completion Date:
December 31, 2028

Study 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).

Connect with a study center

  • Irccs Inrca

    Ancona, Ancona 60129
    Italy

    Active - Recruiting

  • Ospedale San Martino

    Belluno, Italy 32100
    Italy

    Active - Recruiting

  • Ospedale Bufalini

    Cesena, Italy 47521
    Italy

    Active - Recruiting

  • Ospedale di Conegliano - USLL2

    Conegliano, Italy 31015
    Italy

    Site Not Available

  • Ospedale Cardarelli

    Naples, Italy 80131
    Italy

    Active - Recruiting

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Italy 42122
    Italy

    Site Not Available

  • Ospedale Santa Chiara

    Trento, Italy 38123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S. Maria della Misericordia

    Perugia, Perugia 06156
    Italy

    Site Not Available

  • Ospedale Pederzoli

    Peschiera del Garda, Veneto 37019
    Italy

    Active - Recruiting

  • Ospedale Cardarelli

    Napoli, 80131
    Italy

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.