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Recruiting Not applicable

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

NCT06815159 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2020-03-18
Last updated
2025-02-07

Condition(s) studied

AV Fistula

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria:

Primary outcome measure(s)

  • Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis. — From the first patient entrolled, up to the 150th patient, an average of 6 years
    Biomarkers of the treated fistula are histologically examined

Trial sites (1)

FacilityCityRegionStatus
IRCCS AOU di Bologna Policlinico di Sant'Orsola Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06815159 on ClinicalTrials.gov ↗ ← All trials in Italy