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

NCT04197544 | Unknown

• 1 other identifier: FAVIS
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Efficacy and Safety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Procedure: endoFAVI

Control group

NO INTERVENTION

Interventions

endoFAVI PROCEDURE

EndoFAVI creation to patients that require vascular access for hemodialysis.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fernando López Zárraga: lead

Study Sites (1)

Araba University Hospital (Santiago

Vitoria-Gasteiz, Spain

RECRUITING

Study Officials

• Fernando López Zárraga, Dr

  Basque health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando López Zárraga, Dr

CONTACT

0034 945007600; FERNANDO.LOPEZZARRAGA@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: July 28, 2021
• Primary Completion: November 1, 2022
• Study Completion: January 31, 2023
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

ES (1)