Last updated: March 11, 2022
Sponsor: Fernando López Zárraga
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT04197544
FAVIS
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult (older than 18).
- Currently be receiving chronic dialysis, or be waiting to start the chronic dialysisin the next six months.
- Have veins with diameter >= 2.0mm to the creation of the fistula, established byDuplex ultrasound or venogram.
- Have arteries with diameter >= 2.0mm to the creation of the fistula, established byDuplex ultrasound or venogram.
- Cubital and radial arterial flow for the hand, confirmed with Duplex Ultrasound and/orAllen test.
- Dismissed the realization of cephalic-radius FAVI for surgical technical problems.
- Informed Consent to participate in the study.
Exclusion
Exclusion Criteria:
- Known central venous stenosis or narrowing of the central vein > 50% according toimages 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 determinedby 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 FAVcreation.
- Concomitant major surgical procedure "planned" within three months of recruitment ormajor 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 properlypremedicated.
- 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 notgeographically 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 wouldrequire a transposition procedure, defined as the elevation of an objectivecannulation vein nad the creation of a new fistula AV.
- The patient is nit willing to undergo of second stage, defined as a conversion tosurgical FAVI, central catheter arrangement, thrombectomy/rescue fibrinolysis, stenoicarea angioplasty, ...
Study Design
Total Participants: 14
Study Start date:
July 28, 2021
Estimated Completion Date:
January 31, 2023
Connect with a study center
Araba University Hospital (Santiago
Vitoria-Gasteiz,
SpainActive - Recruiting
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