Evaluation of the Implantation of the End-vascular Creation of the Arteriovenous Fistulas in Patients in the University Hospital of Araba. Pilot Study.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Efficacy and Safety
- Sponsor
- Fernando López Zárraga
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Percentage of endoFAVI physiologically appropriate for the hemodialysis during the next three months to the creation.
- Last Updated
- 4 years ago
Overview
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.
Investigators
Fernando López Zárraga
Principal Investigator
Basque Health Service
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Percentage of endoFAVI physiologically appropriate for the hemodialysis during the next three months to the creation.
Time Frame: Three months next 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.