Developmental Venous AnomalyExplor-AVDNCT03986853
Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities
A study testing Blood sampling in people with Developmental Venous Anomaly, run by Hopital Foch at 1 site in France.
Trial summary
The purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Developmental Venous Anomaly
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2018to 11 Jan 2021
- 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
None listed.
Who cannot join
- Presenting a contraindication to the realization of hyperselective cathterism
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia.
- Conditions
- Developmental Venous Anomaly
- Being tested
- Blood sampling
- Medical subject headings
- Central Nervous System Venous Angioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood sampling under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Blood sample | Experimental | Blood sampling Under general anesthesia Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of angiogenic and inflammatory growth factors
The 1st factor studied is VEGF-A
Measured: 1 day
Assessment of angiogenic and inflammatory growth factors
The 2nd factor studied is VEGF-A
Measured: 1 day
Assessment of angiogenic and inflammatory growth factors
The 3rd factor studied is angiopoitin-2
Measured: 1 day
Assessment of angiogenic and inflammatory growth factors
The 4th factor studied is PDGF
Measured: 1 day
Assessment of angiogenic and inflammatory growth factors
The 5th factor studied is angiopoietin-like 4
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start11 Jan 2018
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Why it stopped: Patient with rare disease
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Venous AnomalyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Collège de France
- Responsible party
- Sponsor
- Investigators
- Georges Rodesch, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986853
- Sponsor's protocol ID
- 2017007-F
- Acronym
- Explor-AVD
- Status last verified
- Aug 2022
- First submitted
- 13 Jun 2019
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities
- ClinicalTrials.gov ID
- NCT03986853
- Acronym / sponsor ID
- Explor-AVD / 2017007-F
- Conditions
- Developmental Venous Anomaly
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient with rare disease
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Collège de France
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 14 Jun 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.
The purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample | Experimental | Procedure: Blood samplingBlood sampling Under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Presenting a contraindication to the realization of hyperselective cathterism
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 |
|---|---|---|
| Blood samplingBlood sampling under general anesthesia | Procedure or surgery | Blood sample |
Primary outcome
Assessment of angiogenic and inflammatory growth factors
Time frame: 1 day
The 1st factor studied is VEGF-A
Assessment of angiogenic and inflammatory growth factors
Time frame: 1 day
The 2nd factor studied is VEGF-A
Assessment of angiogenic and inflammatory growth factors
Time frame: 1 day
The 3rd factor studied is angiopoitin-2
Assessment of angiogenic and inflammatory growth factors
Time frame: 1 day
The 4th factor studied is PDGF
Assessment of angiogenic and inflammatory growth factors
Time frame: 1 day
The 5th factor studied is angiopoietin-like 4
Results and safety
The study was stopped early (reason given: Patient with rare disease). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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Recruiting
Inflammatory Marker and Pre-existing Venous Fibrosis to Predict AVF Mal-maturation
Arteriovenous Fistula
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.
Georges Rodesch principal investigator
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Developmental Venous Anomaly, run by Hopital Foch at 1 site in France.
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 0 inclusion and 1 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: stopped early, as of the sponsor's last update on 4 Aug 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 France. 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?
The study was stopped early (reason given: Patient with rare disease). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of angiogenic and inflammatory growth factors (time frame: 1 day). The study lists 5 primary outcomes in all. 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 4 Aug 2022.