Validation of Arterio Venous Access Stage (AVAS) Classification

NCT04796558 | Active Not Recruiting

• 1 other identifier: 532021
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

VAVASC trial is an observational multicentre study. The aim of this trial is to validate AVAS (arteriovenous vascular access stage) classification. The classification is used for determining which type of access is the most suitable for the patient on the basis of the patient´s vascular anatomy The methodology of this trial is to apply AVAS classification on patients who are indicated for creation of vascular access for hemodialysis. Data on these patients (vascular anatomy status, AVAS type, and predicted type of arterio venous access, demographic data etc.) will be than statistically analysed. Patients will then undergo creation of the selected arteriovenous access. They will be observed in terms of the access functionality. The follow up will be 1 to 3 years. The second aim of this study is to evaluate the relationship between AVAS classification and uninterrupted use of the created arterio venous access.

Conditions

Arteriovenous Graft; Arteriovenous Fistula; Dialysis Access Malfunction; Kidney Failure; Dialysis Related Complication

Keywords

Arterio venous access; Dialysis; AVAS; Predictive modelling; Machine learning; VAVASC; Multicentre; Observational; Prospective

Outcome Measures

Primary Outcomes (4)

• Arterio Venous Access Stage (AVAS) evaluation

  What type of the Arterio Venous Access Stage (AVAS classification) the patient has based on his/her vascular anatomy of upper limbs

  Baseline - recruiting (Year 1) - physical examination, data collection and evaluation of Arterio Venous Access Stage (AVAS)

• Arterio Venous Access type predicted

  What type of the Arterio Venous Access is predicted based on AVAS and other clinical factors

  Baseline - recruiting (Year 1) - physical examination, data collection and evaluation of Arterio Venous Access Stage (AVAS) and predicting a type of arterio venous access

• Final Arterio Venous Access

  What type of the arterio venous access was eventually created (in corelation with AVAS evaluation and the predicted arteriovenous access type)

  Follow up (up to 1-2 years) what type of arterio venous access was eventually created

• Functionality of the arterio venous access

  Uninterrupted use of the created arterio venous access

  Year 2-3 - follow up, collection the data about the functionality (uninterrupted use) of the arterio venous access and evaluation of the relation between AVAS and the functionality of the arterio venous access

Interventions

AVAS Classification OTHER

Validation of AVAS classification

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- patients with kidney insufficiency who are indicated for creation of arterio venouss access for dialysis

You may qualify if:

• patients indicated for creation of arterio venous access for dialysis

You may not qualify if:

• patients who disagree to participate in the study

Sponsors & Collaborators

• Vascular surgery, University hospital Královské Vinohrady, Prague: lead
• Belfast Health and Social Care Trust: collaborator

Study Sites (1)

Vascular surgery, University hospital Královské Vinohrady

Prague, 10034, Czechia

Location

Related Publications (2)

• Lawrie K, Waldauf P, Balaz P, Bortel R, Lacerda R, Aitken E, Letachowicz K, D'Oria M, Di Maso V, Stasko P, Gomes A, Fontainhas J, Pekar M, Srdelic A; VAVASC Study Group; O'Neill S. Machine learning validation of the AVAS classification compared to ultrasound mapping in a multicentre study. Sci Rep. 2025 Jan 20;15(1):2538. doi: 10.1038/s41598-025-86456-3.

  PMID: 39833325 DERIVED

• Katerina L, Stephen O, Petr W, Peter B. VAVASC study: Clinical trial protocol. J Vasc Access. 2023 Jul;24(4):792-797. doi: 10.1177/11297298211042677. Epub 2021 Sep 2.

  PMID: 34472988 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Arteriovenous Fistula; Renal Insufficiency

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; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 15, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)