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Peripheral Arterial DiseasePiPERNCT06277362

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

An observational study of Peripheral Arterial Disease and Critical Limb-Threatening Ischemia, run by EndoCore Lab s.r.l. at 9 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
50 participants
Where
9 sitesItaly
Study dates
31 Jan 2020to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects presenting the most advanced stage of lower limb arterial disease, defined as patients with CLTI and no indication for revascularization.

Who may be able to join

  • 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%

Who cannot join

  • 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%

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gabriele Morselli, PharmD contact

+39 3499105666

g.morselli@endocorelab.org

Bruno Migliara, MD contact

bruno.migliara@gmail.com

9 sites in 1 country

Italy9 sites, 7 recruiting

  • Irccs Inrca

    Ancona, Ancona, 60129

    Enrico Paci, MD

    Recruiting

  • Ospedale San Martino

    Belluno, Italy, 32100

    Sandro Irsara, MD

    Luca Ferretto, MD

    Recruiting

  • Ospedale Bufalini

    Cesena, Italy, 47521

    Gabriele Testi, MD

    Gabriele Testi, MD

    Recruiting

  • Ospedale di Conegliano - USLL2

    Conegliano, Italy, 31015

    Withdrawn

  • Ospedale Cardarelli

    Naples, Italy, 80131

    Gianluca Cangiano, MD

    Gianluca Cangiano, MD

    Recruiting

  • Azienda Ospedaliera S. Maria della Misericordia

    Perugia, Perugia, 06156

    Massimo Lenti, MD

    Not yet recruiting

  • Ospedale Pederzoli

    Peschiera del Garda, Veneto, 37019

    Bruno Migliara, MD, bruno.migliara@gmail.com

    Recruiting

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Italy, 42122

    Withdrawn

  • Ospedale Santa Chiara

    Trento, Italy, 38123

    Stefano Bonvini, MD

    Stenano Bonvini, MD

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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).

Keywords
PAD, DVA, CLTI
Medical subject headings
Peripheral Arterial Disease, Diabetic Foot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days, 6 months

Secondary outcomes (13)

  1. 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);

    Measured: Day 1

  2. Primary Patency

    Primary patency defined as no occlusion of the arterialized vein tract

    Measured: 30 days, 3 months, 6 months, 12 months and 24 months

  3. Secondary Patency

    Secondary patency defined as no secondary occlusion of the arterialised vein tract

    Measured: 30 days, 3 months, 6 months, 12 months and 24 months

  4. A-V fistula flow rate

    A-V fistula flow rate

    Measured: 30 days, 3 months, 6 months, 12 months and 24 months

  5. Minor amputation rates

    Minor amputation rates defined as a below the ankle amputation

    Measured: 30 days, 3 months, 6 months, 12 months and 24 months

  6. Major amputation rates

    Major amputation rates defined as an above the ankle amputation

    Measured: 30 days, 3 months, 6 months, 12 months and 24 months

  7. Re-Treatment rate

    Re-Treatment rate defined as need for reintervention

    Measured: 30 days, 3 months, 6 months, 12 months and 24 months

  8. Wound Size

    Wound Size defined as wound size reduction index

    Measured: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months

  9. TpcO2

    TpcO2 defined as TpcO2 value changes

    Measured: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months

  10. WIFi class

    WIFi class and stage changes

    Measured: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months

  11. Freedom from all cause death

    Freedom from all cause death

    Measured: 30 days, 3 months, 6 months, 12 months and 24 months

  12. Freedom from procedure-related death

    Freedom from procedure-related death

    Measured: 30 days, 3 months

  13. Rutherford class

    Rutherford class and stage changes

    Measured: Baseline, 30 days, 3 months, 6 months, 12 months and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start31 Jan 2020
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277362
Sponsor's protocol ID
CLTI012023
Acronym
PiPER
Status last verified
Mar 2026
First submitted
19 Feb 2024
Last updated
24 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease and Critical Limb-Threatening Ischemia, run by EndoCore Lab s.r.l. at 9 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gabriele Morselli, PharmD (+39 3499105666, g.morselli@endocorelab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Composite (time frame: 30 days, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06277362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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