Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis

NCT06815159 | Recruiting

• 1 other identifier: FAV-2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital. POPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to reoperation for correction of complication and/or new AVF by proximalization, as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.

Conditions

AV Fistula

Outcome Measures

Primary Outcomes (1)

• Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.

  Biomarkers of the treated fistula are histologically examined

  From the first patient entrolled, up to the 150th patient, an average of 6 years

Secondary Outcomes (2)

• Different expression of tissue markers before and during dialysis.

  From the first patient enrolled to the 150th patient, an average of 6 years

• Markers differences between Basilic and cephalic vein

  From the first patient enrolled, up to the 150th patient, up to 6 years

Study Arms (2)

First FAV

EXPERIMENTAL

Group of patient with first FAV

Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.

Secondary FAV

EXPERIMENTAL

Group of patients with reintervention of FAV

Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.

Interventions

Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis. BIOLOGICAL

Primary objective 1. Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis. Secondary objectives 2. Compare the results on the possible different expression of tissue markers before and during dialysis. 3. Compare the results on the possible different expression of tissue markers between AVFs made with portions of cephalic vein and AVFs made with portions of basilic vein, in order to evaluate whether the different topographic origin of the AVF can influence its duration.

First FAV; Secondary FAV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years;
• Patients candidates for first AVF for hemodialysis or correction of AVF complication, as part of the normal care pathway;
• Obtaining informed consent signed by the patient

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Dialysis

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Mauro Gargiulo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro Gargiulo, MD

CONTACT

0512143288; mauro.gargiulo2@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery POPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to re-intervention for correction of complication and/or new AVF by proximalization,

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 7, 2025
• Study Start: March 18, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-11

Locations

IT (1)