NCT06277362

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
32mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jan 2020Dec 2028

Study Start

First participant enrolled

January 31, 2020

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

8.8 years

First QC Date

February 19, 2024

Last Update Submit

March 23, 2026

Conditions

Diabetic FootPeripheral Arterial DiseaseCritical Limb-Threatening Ischemia

Keywords

PADDVACLTI

Outcome Measures

Primary Outcomes (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.

    30 days, 6 months

Secondary Outcomes (13)

  • Procedural Success

    Day 1

  • Primary Patency

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

  • Secondary Patency

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

  • A-V fistula flow rate

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

  • Minor amputation rates

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

  • +8 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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%

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Irccs Inrca

Ancona, Ancona, 60129, Italy

RECRUITING

Ospedale San Martino

Belluno, Italy, 32100, Italy

RECRUITING

Ospedale Bufalini

Cesena, Italy, 47521, Italy

RECRUITING

Ospedale di Conegliano - USLL2

Conegliano, Italy, 31015, Italy

WITHDRAWN

Ospedale Cardarelli

Naples, Italy, 80131, Italy

RECRUITING

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, 42122, Italy

WITHDRAWN

Ospedale Santa Chiara

Trento, Italy, 38123, Italy

RECRUITING

Azienda Ospedaliera S. Maria della Misericordia

Perugia, Perugia, 06156, Italy

NOT YET RECRUITING

Ospedale Pederzoli

Peschiera del Garda, Veneto, 37019, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial DiseaseDiabetic Foot

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesDiabetic AngiopathiesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Gabriele Morselli, PharmD

    EndocoCore Lab s.r.l.

    STUDY DIRECTOR

  • Bruno Migliara, MD

    Casa di Cura Pederzoli

    PRINCIPAL INVESTIGATOR

  • Marco Manzi, MD

    Casa di Cura Abano Terme

    STUDY CHAIR

Central Study Contacts

Gabriele Morselli, PharmD

CONTACT

+39 3499105666g.morselli@endocorelab.org

Bruno Migliara, MD

CONTACT

bruno.migliara@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 26, 2024

Study Start

January 31, 2020

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

IT(9)