Efficacy and SafetyNCT04197544
Evaluation of the Implantation of the End-vascular Creation of the Arteriovenous Fistulas in Patients in the University Hospital of Araba. Pilot Study.
A study testing endoFAVI in people with Efficacy and Safety, run by Fernando López Zárraga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- endoFAVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jul 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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, ...
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Araba University Hospital (Santiago
Vitoria-Gasteiz
Fernando López Zárraga, Dr., 0034 945 007600
About this study
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
- Being tested
- endoFAVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoFAVIProcedure or surgery
EndoFAVI creation to patients that require vascular access for hemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Procedure: endoFAVI |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months next the creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start28 Jul 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernando López Zárraga
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Fernando López Zárraga, Basque Health Service
- Investigators
- Fernando López Zárraga, Dr, Principal investigator, Basque health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197544
- Sponsor's protocol ID
- FAVIS
- Status last verified
- Mar 2022
- First submitted
- 11 Dec 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04197544
- Acronym / sponsor ID
- FAVIS
- Conditions
- Efficacy and Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Fernando López ZárragaOther government
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: endoFAVI |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoFAVIEndoFAVI creation to patients that require vascular access for hemodialysis. | Procedure or surgery | Intervention group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando López Zárraga, Dr principal investigator
Basque health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoFAVI in people with Efficacy and Safety, run by Fernando López Zárraga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando López Zárraga, Dr (0034 945007600, FERNANDO.LOPEZZARRAGA@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of endoFAVI physiologically appropriate for the hemodialysis during the next three months to the creation. (time frame: Three months next the creation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.