Dural Arteriovenous FistulaNAIF 2NCT07824297
NAIF 2.0 - COGNIFY
An observational study of Dural Arteriovenous Fistula and Glymphatic System, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in 3 countries.
Trial summary
The goal of this observational study is to learn whether intracranial dural arteriovenous fistulae, abnormal connections between arteries and veins in the covering of the brain, may affect a brain's waste-clearance system, known as the glymphatic system. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dural Arteriovenous Fistula, Glymphatic System
- What is being tested?
- Brain MRI
- How many people
- 20 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jan 2026to 1 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angiographically confirmed diagnosis of unruputred intracranial dAVFs, aged 18-99 years, candidate for endovascular embolization treatment with curative intent.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 to 99 years.
- Angiographically confirmed diagnosis of unruptured intracranial dAVF.
- Candidate for endovascular embolization treatment with curative intent.
- Able to undergo Brain MRI.
Who cannot join
- Contraindication to angiographic embolization procedures.
- Acute intracranial haemorrhage secondary to dAVFs rupture and/or venous hypertension.
- Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study, other contraindications to MRI such as certain metallic implants.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Italy1 site, 1 recruiting
- Not yet recruiting
Università di Bologna
Bologna, 40127
Claudia Testa, PhD, +390512095119, claudia.testa@unibo.it
Alessandro Carrozzi, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Vall D'Hebron
Barcelona, 08035
Laura Ludovica Gramegna, MD, PhD, +34934893000, laura.gramegna@vhir.org
Alejandro Tomasello, MD, alejandro.tomasello.idi@gencat.cat
United Kingdom1 site, 1 recruiting
- Not yet recruiting
University of Oxford
Oxford, OX3 9DU
Yan-Lin Li, MD, +4401865231669, Yan-Lin.Li@ouh.nhs.uk
James Grist, PhD
About this study
Official title: NAIF 2.0 - COGNIFY: Cognitive Impairment in Patients With Intracranial Dural Arteriovenous Fistulae: Exploration & Understanding
The goal of this observational study is to learn whether intracranial dural arteriovenous fistulae, abnormal connections between arteries and veins in the covering of the brain, may affect a brain's waste-clearance system, known as the glymphatic system.
The main question it aims to answer is: "Does glymphatic system function change after routine endovascular embolization of an intracranial dural arteriovenous fistula?" Participants who are already scheduled to receive endovascular embolization as part of their regular medical care will undergo advanced brain MRI before treatment and again about 6 months after treatment. Researchers will compare the MRI findings before and after embolization to explore whether treatment is associated with changes in glymphatic-related brain imaging markers.
Read the detailed description
Intracranial dural arteriovenous fistulae (dAVF) are acquired vascular malformations characterized by an abnormal connection between dural arteries and cortical veins or dural sinuses, characterized by altered venous drainage. Treatment decision has traditionally been driven by risk of rupture and brain haemorrhage, although recent findings from the NAIF study showed that patients with dAVF may also present with cognitive impairment that can improve after successful endovascular embolization (Gramegna et al., 2023). However, the mechanisms underlying this potentially reversible cognitive dysfunction remain poorly understood.
Abnormal venous pressure and flow may disrupt brain homeostasis and interfere with the glymphatic system, a clearance pathway closely linked to perivascular spaces and meningeal lymphatic vessels, whose function is determined by a correct pressure gradient between arteries and veins. Glymphatic dysfunction has been associated with cognitive impairment in neurodegenerative and cerebrovascular disorders and its alterations appear to be reversible following pharmacological or surgical interventions.
NAIF 2 hypothesizes that altered venous drainage in dAVF causes glymphatic dysfunction that may improve after endovascular treatment. Our study protocol is centred around an advanced multishell diffusion-weighted MRI which will be used to assess in vivo and non-invasively this hypothesis. From diffusion-weighted images, metrics related to glymphatic system function will be computed, mainly DTI-ALPS (Taoka et al., 2017), together with diffusion kurtosis imaging-derived mean kurtosis (DKI-MK) and free-water (FW) imaging, which may provide complementary information on microstructural and interstitial fluid alterations (Sacchi et al., 2024).
This prospective multicentre observational study will recruit patients with angiographically confirmed unruptured dAVF undergoing embolization at Vall d'Hebron University Hospital and Oxford University Hospitals, with methodological support from the University of Bologna. Two MRI session are planned: one at baseline and one approximately 6 moths after treatment. Advanced MRI-derived glymphatic metrics will be compared before and after embolization, with changes in DTI-ALPS, DKI-MK, and FW measures as the primary endpoint. Demonstrating reversible glymphatic dysfunction could provide a biological explanation for cognitive impairment related to dAVF and its recovery after embolization and help to reconsider how a treatment decision is taken, especially in low-grade fistulae, considering other factors beyond haemorrhagic risk alone.
- Conditions
- Dural Arteriovenous Fistula, Glymphatic System
- Being tested
- Brain MRI
- Keywords
- MRI, DTI, Glymphatic System, Dural Arteriovenous Fistula
- Medical subject headings
- Central Nervous System Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIDiagnostic test
Participants will undergo a brain MRI on a 3T scanner at baseline assessment and approximately 6 months after endovascular embolization. The MRI protocol includes routinary morphologic sequences (e.g., 3D T1-weighted imaging, T2-weighted FLAIR, susceptibility-weighted imaging), as well as a multi-shell diffusion MRI with multiple b-values and gradient directions. These sequences will be used to assess conventional brain findings and diffusion-derived metrics potentially related to glymphatic function, including DTI-ALPS, DKI-MK and FW imaging. The main otcome of the study is to evaluate changes in these metrics in relation to treatment.
| Study group | Role | What they receive |
|---|---|---|
| dAVF patients | Patients with angiografically confirmed diagnosis of intracranial dAVF, aged 18-99 years, candidate for endovascular will be invited to participate in this study Receives: Diagnostic Test: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean DTI-ALPS Index at Baseline and 6 Months After Endovascular Embolization
The diffusion tensor imaging-analysis along the perivascular space (DTI-ALPS) index will be calculated from directional diffusivities measured in prespecified projection- and association-fiber regions of interest (ROIs). The regional measurements will be combined according to the prespecified DTI-ALPS calculation to obtain one DTI-ALPS index per participant at each time point. DTI-ALPS values will be summarized as the mean and standard deviation at baseline and follow-up. Baseline and follow-up values will be compared within participants using a two-sided paired-samples t-test. A Wilcoxon signed-rank test will be performed as a sensitivity analysis if marked departures from normality or influential outliers are identified. Lower DTI-ALPS values indicate greater lower diffusivity along the perivascular-space direction, suggestive of a glymphatic system impairment. The DTI-ALPS index is unitless.
Measured: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
Mean MK at Baseline and 6 Months After Endovascular Embolization
Mean Kurtosis (MK) will be derived from multi-shell diffusion MRI. Voxelwise mean kurtosis values within white matter ROIs covering the whole brain will be calculated and summarized as the mean and standard deviation at baseline and follow-up. Baseline and follow-up values will be compared within participants using a two-sided paired-samples t-test. A Wilcoxon signed-rank test will be performed as a sensitivity analysis if marked departures from normality or influential outliers are identified. Higher mean kurtosis values indicate a greater degree of non-Gaussian water diffusion, suggestive of a glymphatic system impairment. MK is unitless.
Measured: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
Mean FW at Baseline and 6 Months After Endovascular Embolization
Free-water (FW) will be estimated from multi-shell diffusion MRI using a free-water imaging model. Voxelwise FW values within white matter ROIs covering the whole brain will be calculated and summarized as the mean and standard deviation at baseline and follow-up. Baseline and follow-up values will be compared within participants using a two-sided paired-samples t-test. A Wilcoxon signed-rank test will be performed as a sensitivity analysis if marked departures from normality or influential outliers are identified. FW is a unitless volume fraction ranging from 0 to 1, with higher values indicating a greater proportion of extracellular free water, suggestive of a glymphatic system impairment.
Measured: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
Secondary outcomes (3)
Spearman Rank Correlation Between Cognard Grade and Baseline DTI-ALPS Index
dAVF severity will be assessed by digital subtraction angiography using the Cognard classification and treated as an ordinal variable. The DTI-ALPS index will be derived from diffusion MRI and expressed as a unitless index. The association between Cognard grade and baseline DTI-ALPS index will be assessed using Spearman's rank correlation coefficient. Results will be reported as Spearman's rho with a 95% confidence interval.
Measured: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
Spearman Rank Correlation Between Cognard Grade and Baseline MK
dAVF severity will be assessed by digital subtraction angiography using the Cognard classification and treated as an ordinal variable. MK will be derived from multi-shell diffusion kurtosis imaging and expressed as a unitless value. The association between Cognard grade and baseline mean kurtosis will be assessed using Spearman's rank correlation coefficient. Results will be reported as Spearman's rho with a 95% confidence interval.
Measured: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization
Spearman Rank Correlation Between Cognard Grade and Baseline FW
dAVF severity will be assessed by digital subtraction angiography using the Cognard classification and treated as an ordinal variable. FW will be derived from multi-shell diffusion MRI and expressed as a unitless fraction ranging from 0 to 1. The association between Cognard grade and baseline free-water fraction will be assessed using Spearman's rank correlation coefficient. Results will be reported as Spearman's rho with a 95% confidence interval.
Measured: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jan 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dural Arteriovenous FistulaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna, University of Oxford, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824297
- Sponsor's protocol ID
- PR(AG)181/2024
- Other IDs
- ERP-2025-14067
- Acronym
- NAIF 2
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sacchi L, D'Agata F, Campisi C, Arcaro M, Carandini T, Orzsik B, Dal Maschio VP, Fenoglio C, Pietroboni AM, Ghezzi L, Serpente M, Pintus M, Conte G, Triulzi F, Lopiano L, Galimberti D, Cercignani M, Bozzali M, Arighi A. A "glympse" into neurodegeneration: Diffusion MRI and cerebrospinal fluid aquaporin-4 for the assessment of glymphatic system in Alzheimer's disease and other dementias. Hum Brain Mapp. 2024 Aug 15;45(12):e26805. doi: 10.1002/hbm.26805.
PubMed 39185685Taoka T, Masutani Y, Kawai H, Nakane T, Matsuoka K, Yasuno F, Kishimoto T, Naganawa S. Evaluation of glymphatic system activity with the diffusion MR technique: diffusion tensor image analysis along the perivascular space (DTI-ALPS) in Alzheimer's disease cases. Jpn J Radiol. 2017 Apr;35(4):172-178. doi: 10.1007/s11604-017-0617-z. Epub 2017 Feb 14.
PubMed 28197821Gramegna LL, Ortega G, Dinia L, Aixut S, Rosati S, Vega P, Luttich A, Remollo S, Gonzalez A, Murias E, Chirife Chaparro O, Moreu M, Requena M, de Dios Lascuevas M, Hernandez D, Quintana M, Puig J, Rovira A, Tomasello A. Cognitive improvement following endovascular embolization in patients with intracranial dural arteriovenous fistula: The Neuropsychology in dural ArterIal Fistula (NAIF) Study. J Neurointerv Surg. 2023 Dec 7:jnis-2023-021033. doi: 10.1136/jnis-2023-021033. Online ahead of print.
PubMed 38071581
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAIF 2.0 - COGNIFY: Cognitive Impairment in Patients With Intracranial Dural Arteriovenous Fistulae: Exploration & Understanding
- ClinicalTrials.gov ID
- NCT07824297
- Acronym / sponsor ID
- NAIF 2 / PR(AG)181/2024
- Conditions
- Dural Arteriovenous Fistula, Glymphatic System
- Keywords
- MRI, DTI, Glymphatic System, Dural Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- University of Bologna, University of Oxford, Oxford University Hospitals NHS Trust
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 17 Sep 2026 (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.
The goal of this observational study is to learn whether intracranial dural arteriovenous fistulae, abnormal connections between arteries and veins in the covering of the brain, may affect a brain's waste-clearance system, known as the glymphatic system.
The main question it aims to answer is: "Does glymphatic system function change after routine endovascular embolization of an intracranial dural arteriovenous fistula?" Participants who are already scheduled to receive endovascular embolization as part of their regular medical care will undergo advanced brain MRI before treatment and again about 6 months after treatment. Researchers will compare the MRI findings before and after embolization to explore whether treatment is associated with changes in glymphatic-related brain imaging markers.
Detailed description
Intracranial dural arteriovenous fistulae (dAVF) are acquired vascular malformations characterized by an abnormal connection between dural arteries and cortical veins or dural sinuses, characterized by altered venous drainage. Treatment decision has traditionally been driven by risk of rupture and brain haemorrhage, although recent findings from the NAIF study showed that patients with dAVF may also present with cognitive impairment that can improve after successful endovascular embolization (Gramegna et al., 2023). However, the mechanisms underlying this potentially reversible cognitive dysfunction remain poorly understood.
Abnormal venous pressure and flow may disrupt brain homeostasis and interfere with the glymphatic system, a clearance pathway closely linked to perivascular spaces and meningeal lymphatic vessels, whose function is determined by a correct pressure gradient between arteries and veins. Glymphatic dysfunction has been associated with cognitive impairment in neurodegenerative and cerebrovascular disorders and its alterations appear to be reversible following pharmacological or surgical interventions.
NAIF 2 hypothesizes that altered venous drainage in dAVF causes glymphatic dysfunction that may improve after endovascular treatment. Our study protocol is centred around an advanced multishell diffusion-weighted MRI which will be used to assess in vivo and non-invasively this hypothesis. From diffusion-weighted images, metrics related to glymphatic system function will be computed, mainly DTI-ALPS (Taoka et al., 2017), together with diffusion kurtosis imaging-derived mean kurtosis (DKI-MK) and free-water (FW) imaging, which may provide complementary information on microstructural and interstitial fluid alterations (Sacchi et al., 2024).
This prospective multicentre observational study will recruit patients with angiographically confirmed unruptured dAVF undergoing embolization at Vall d'Hebron University Hospital and Oxford University Hospitals, with methodological support from the University of Bologna. Two MRI session are planned: one at baseline and one approximately 6 moths after treatment. Advanced MRI-derived glymphatic metrics will be compared before and after embolization, with changes in DTI-ALPS, DKI-MK, and FW measures as the primary endpoint. Demonstrating reversible glymphatic dysfunction could provide a biological explanation for cognitive impairment related to dAVF and its recovery after embolization and help to reconsider how a treatment decision is taken, especially in low-grade fistulae, considering other factors beyond haemorrhagic risk alone.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dAVF patients | – | Diagnostic Test: Brain MRIPatients with angiografically confirmed diagnosis of intracranial dAVF, aged 18-99 years, candidate for endovascular will be invited to participate in this study |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angiographically confirmed diagnosis of unruputred intracranial dAVFs, aged 18-99 years, candidate for endovascular embolization treatment with curative intent.
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 to 99 years.
- Angiographically confirmed diagnosis of unruptured intracranial dAVF.
- Candidate for endovascular embolization treatment with curative intent.
- Able to undergo Brain MRI.
Key exclusion criteria (3 listed)
- Contraindication to angiographic embolization procedures.
- Acute intracranial haemorrhage secondary to dAVFs rupture and/or venous hypertension.
- Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study, other contraindications to MRI such as certain metallic implants.
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 |
|---|---|---|
| Brain MRIParticipants will undergo a brain MRI on a 3T scanner at baseline assessment and approximately 6 months after endovascular embolization. The MRI protocol includes routinary morphologic sequences (e.g., 3D T1-weighted imaging, T2-weighted FLAIR, susceptibility-weighted imaging), as well as a multi-shell diffusion MRI with multiple b-values and gradient directions. These sequences will be used to assess conventional brain findings and diffusion-derived metrics potentially related to glymphatic function, including DTI-ALPS, DKI-MK and FW imaging. The main otcome of the study is to evaluate changes in these metrics in relation to treatment. | Diagnostic test | dAVF patients |
Primary outcome
Mean DTI-ALPS Index at Baseline and 6 Months After Endovascular Embolization
Time frame: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
The diffusion tensor imaging-analysis along the perivascular space (DTI-ALPS) index will be calculated from directional diffusivities measured in prespecified projection- and association-fiber regions of interest (ROIs). The regional measurements will be combined according to the prespecified DTI-ALPS calculation to obtain one DTI-ALPS index per participant at each time point. DTI-ALPS values will be summarized as the mean and standard deviation at baseline and follow-up. Baseline and follow-up values will be compared within participants using a two-sided paired-samples t-test. A Wilcoxon signed-rank test will be performed as a sensitivity analysis if marked departures from normality or influential outliers are identified. Lower DTI-ALPS values indicate greater lower diffusivity along the perivascular-space direction, suggestive of a glymphatic system impairment. The DTI-ALPS index is unitless.
Mean MK at Baseline and 6 Months After Endovascular Embolization
Time frame: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
Mean Kurtosis (MK) will be derived from multi-shell diffusion MRI. Voxelwise mean kurtosis values within white matter ROIs covering the whole brain will be calculated and summarized as the mean and standard deviation at baseline and follow-up. Baseline and follow-up values will be compared within participants using a two-sided paired-samples t-test. A Wilcoxon signed-rank test will be performed as a sensitivity analysis if marked departures from normality or influential outliers are identified. Higher mean kurtosis values indicate a greater degree of non-Gaussian water diffusion, suggestive of a glymphatic system impairment. MK is unitless.
Mean FW at Baseline and 6 Months After Endovascular Embolization
Time frame: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
Free-water (FW) will be estimated from multi-shell diffusion MRI using a free-water imaging model. Voxelwise FW values within white matter ROIs covering the whole brain will be calculated and summarized as the mean and standard deviation at baseline and follow-up. Baseline and follow-up values will be compared within participants using a two-sided paired-samples t-test. A Wilcoxon signed-rank test will be performed as a sensitivity analysis if marked departures from normality or influential outliers are identified. FW is a unitless volume fraction ranging from 0 to 1, with higher values indicating a greater proportion of extracellular free water, suggestive of a glymphatic system impairment.
3 secondary outcomes
Spearman Rank Correlation Between Cognard Grade and Baseline DTI-ALPS Index
Time frame: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
Spearman Rank Correlation Between Cognard Grade and Baseline MK
Time frame: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization
Spearman Rank Correlation Between Cognard Grade and Baseline FW
Time frame: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Results publication: PubMed 39185685Sacchi L, D'Agata F, Campisi C, Arcaro M, Carandini T, Orzsik B, Dal Maschio VP, Fenoglio C, Pietroboni AM, Ghezzi L, Serpente M, Pintus M, Conte G, Triulzi F, Lopiano L, Galimberti D, Cercignani M, Bozzali M, Arighi A. A "glympse" into neurodegeneration: Diffusion MRI and cerebrospinal fluid aquaporin-4 for the assessment of glymphatic system in Alzheimer's disease and other dementias. Hum Brain Mapp. 2024 Aug 15;45(12):e26805. doi: 10.1002/hbm.26805.
- Results publication: PubMed 28197821Taoka T, Masutani Y, Kawai H, Nakane T, Matsuoka K, Yasuno F, Kishimoto T, Naganawa S. Evaluation of glymphatic system activity with the diffusion MR technique: diffusion tensor image analysis along the perivascular space (DTI-ALPS) in Alzheimer's disease cases. Jpn J Radiol. 2017 Apr;35(4):172-178. doi: 10.1007/s11604-017-0617-z. Epub 2017 Feb 14.
- Results publication: PubMed 38071581Gramegna LL, Ortega G, Dinia L, Aixut S, Rosati S, Vega P, Luttich A, Remollo S, Gonzalez A, Murias E, Chirife Chaparro O, Moreu M, Requena M, de Dios Lascuevas M, Hernandez D, Quintana M, Puig J, Rovira A, Tomasello A. Cognitive improvement following endovascular embolization in patients with intracranial dural arteriovenous fistula: The Neuropsychology in dural ArterIal Fistula (NAIF) Study. J Neurointerv Surg. 2023 Dec 7:jnis-2023-021033. doi: 10.1136/jnis-2023-021033. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dural Arteriovenous Fistula and Glymphatic System, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in 3 countries.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Spain, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Ludovica Gramegna, MD, PhD (+34934893000, laura.gramegna@vhir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean DTI-ALPS Index at Baseline and 6 Months After Endovascular Embolization (time frame: Baseline/pre-treatment MRI and follow-up MRI approximately 6 months after endovascular embolization.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07824297, which also lists 3 linked publications.
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 17 Sep 2026.