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

NCT ID: NCT04197544

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2023-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

endoFAVI

Intervention Type: PROCEDURE

EndoFAVI creation to patients that require vascular access for hemodialysis.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

endoFAVI

EndoFAVI creation to patients that require vascular access for hemodialysis.

Intervention Type: PROCEDURE

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, ...

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fernando López Zárraga

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fernando López Zárraga

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fernando López Zárraga, Dr

Role: PRINCIPAL_INVESTIGATOR

Basque health System

Locations

Araba University Hospital (Santiago

Vitoria-Gasteiz, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Fernando López Zárraga, Dr

Role: CONTACT

FERNANDO.LOPEZZARRAGA@osakidetza.eus

0034 945007600

Facility Contacts

Fernando López Zárraga, Dr.

Role: primary

0034 945 007600

Other Identifiers

FAVIS

Identifier Type: -

Identifier Source: org_study_id