Clinical trial NCT04197544: Evaluation of the Implantation of the End-vascular Creation of the Arteriovenous Fistulas in Patients in the University Hospital of Araba. Pilot Study.
Official title: Evaluation of the Implantation of the End-vascular Creation of the Arteriovenous Fistulas in Patients in the University Hospital of Araba. Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Efficacy and Safety
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2019-12-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.
* 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, ...

Primary outcomes:
measure: Percentage of endoFAVI physiologically appropriate for the hemodialysis during the next three months to the creation.
timeFrame: Three months next the creation
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Araba University Hospital (Santiago
Study officials:
affiliation: Basque health System
name: Fernando López Zárraga, Dr
role: PRINCIPAL_INVESTIGATOR
References: