Evaluation of the Implantation of the End-vascular Creation of the Arteriovenous Fistulas in Patients in the University Hospital of Araba. Pilot Study.

In last few years, there is a new technology that permits the endovascular fistula creation with a minimum vascular trauma and the first results show encouraging results with high technical success rate, low resurgent and failure rates and good usability for hemodialysis.

The implementation of the endoFAVI realization in dialysis patients is an emergent procedure that in our hospital can contribute important benefits to the patients, savings to the health system, as well research and innovation in the implicate services.

Study Overview

• Status: Recruiting
• Conditions: Efficacy and Safety
• Intervention / Treatment: Procedure: endoFAVI

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando López Zárraga, Dr; Phone Number: 0034 945007600; Email: FERNANDO.LOPEZZARRAGA@osakidetza.eus

Study Locations

• Spain
  • Vitoria-Gasteiz, Spain
    • Recruiting
    • Araba University Hospital (Santiago
    • Contact: Fernando López Zárraga, Dr.; Phone Number: 0034 945 007600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult (older than 18).
• Currently be receiving chronic dialysis, or be waiting to start the chronic dialysis in the next six months.
• Have veins with diameter >= 2.0mm to the creation of the fistula, established by Duplex ultrasound or venogram.
• Have arteries with diameter >= 2.0mm to the creation of the fistula, established by Duplex ultrasound or venogram.
• Cubital and radial arterial flow for the hand, confirmed with Duplex Ultrasound and/or Allen test.
• Dismissed the realization of cephalic-radius FAVI for surgical technical problems.
• Informed Consent to participate in the study.

Exclusion Criteria:

• Known central venous stenosis or narrowing of the central vein > 50% according to images on the same side as the creation of the planned FAV.
• Absence of perforator that feed the target cannulation, by venogram.
• Occlusion or stenosis > 50% of the cephalic basilica vein of the target cannulation.
• Cannulation target vein of less than 2.0 mm of diameter.
• Significantly compromised flow (>= 50% of stenosis) in the treatment arm as determined by the doctor and the images.
• Ejection fraction documented <= 35% in the last 6 months.
• Pregnant women.
• Heart failure Class III or IV of the New York Heart Association (NYHA).
• Hypercouagulability status demonstrated ( Antiphospholipid Syndrome, Leiden factor V, Protein deficit S, ...).
• Known hemorrhagic diathesis.
• Documented history of drug abuse including intravenous drugs within six months of FAV creation.
• Concomitant major surgical procedure "planned" within three months of recruitment or major previous surgery within 30 days of recruitment.
• Known iodine contrast allergy that cannot be properly premedicated.
• Known adverse effects for sedation and/or anesthesia that cannot be properly premedicated.
• Evidence of active infections on the day of the index procedure.
• Life expectancy < 1 year.
• The patient is not willing to provide an written informed consent, is not geographically stable and/or is not willing to cmply with the required follow-up.
• Patient with an objective cannulation vein of more than 6 mm of deep that would require a transposition procedure, defined as the elevation of an objective cannulation vein nad the creation of a new fistula AV.
• The patient is nit willing to undergo of second stage, defined as a conversion to surgical FAVI, central catheter arrangement, thrombectomy/rescue fibrinolysis, stenoic area angioplasty, ...

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	Procedure: endoFAVI; EndoFAVI creation to patients that require vascular access for hemodialysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of endoFAVI physiologically appropriate for the hemodialysis during the next three months to the creation.	The absence of stenosis and thrombosis of the fistula and the racial artery flow >=500 mL/min and the vein diameter >= 5 mm measured by duplex ultrasonography, or successful administration of hemodialysis with 2 needles with flow >= 350 mL/min.	Three months next the creation

Collaborators and Investigators

• Sponsor: Fernando López Zárraga
• Investigators: Principal Investigator: Fernando López Zárraga, Dr, Basque health System

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: FAVIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No