Arteriovenous Malformation of Central Nervous SystempAVM-rFANCT07050381
The Risk Factors Related to Rupture Flow-related Aneurysms in Posterior AVM
An observational study of Arteriovenous Malformation of Central Nervous System and Aneurysm, Ruptured, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
Trial summary
AVMs have been reported to rupture at a formidable annual rate of 2% to 3% at natural progression, often resulting in longterm neurological deficits and poor functional outcomes.The reported risk of hemorrhagic presentation in patients with AVMs is 41% to 65%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arteriovenous Malformation of Central Nervous System, Aneurysm, Ruptured, Aneurysmatic Subarachnoid Haemorrhage
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 13 Jun 2025to 31 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with posterior circulation malformations combined with ruptured or unruptured flow-related aneurysms will be included. Morphological data such as aneurysm size, location, parent artery, feeding arteries, draining vein count, malformation size, malformation location, and the ratio of malformation/aneurysm volume will be analyzed. These factors will be examined alongside medical histories of hypertension, diabetes, and coronary artery disease to investigate the risk factors for ruptured flow-related aneurysms.
Who may be able to join
- pAVM with flow-related aneurysms were identified by DSA, and subarachnoid hemorrhage was confirmed by CT
- No history of stroke, Marfan syndrome, polycystic kidney disease
Who cannot join
- pAVM without flow-related aneurysms
- Absence of clinical data
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Active, not recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 225500
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Hua Lu, +86-18761671021, luhua@njmu.cn
About this study
Official title: Risk Factors Related to Rupture Flow-related Aneurysms in Posterior Arteriovenious Malformation: A Muti-center Observentional Research.
AVMs have been reported to rupture at a formidable annual rate of 2% to 3% at natural progression, often resulting in longterm neurological deficits and poor functional outcomes.The reported risk of hemorrhagic presentation in patients with AVMs is 41% to 65%. While many studies suggest a correlation between higher hemorrhage risk and the concurrent presence of AVM and aneurysms, few authors have focused specifically on flow-related aneurysms alone. In many instances, the source of rupture is also unclear. Meta-analysis from 2016 suggested that 49.2% of hemorrhages were secondary to aneurysm rupture, 45% from AVM rupture, and 5.7% were undetermined.In a study of 302 patients, of which 52.6% had a hemorrhagic presentation, demonstrated a significant increase in rate of hemorrhage in those with flow-related aneurysms. Thus, it is necessary to figure out risk factors related to ruptured flow-related aneurysms in pAVM.
- Conditions
- Arteriovenous Malformation of Central Nervous System, Aneurysm, Ruptured, Aneurysmatic Subarachnoid Haemorrhage, Aneurysm Cerebral
- Keywords
- arteriovenous malformation, flow-related aneurysm, ruptured aneurysm, subarachnoid hemorrhage
- Medical subject headings
- Aneurysm, Ruptured, Intracranial Aneurysm, Arteriovenous Malformations, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pAVM with ruptured flow-related aneurysm | Not described | |
| pAVM without ruptured flow-related aneurysm | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
characteristics of flow-related aneurysm
size ratio(aneurysm depth (mm)/parent artery diameter (mm))
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start13 Jun 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous Malformation of Central Nervous SystemStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Hua, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050381
- Sponsor's protocol ID
- pAVM-rFA
- Acronym
- pAVM-rFA
- Status last verified
- Jun 2025
- First submitted
- 10 Feb 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hung AL, Yang W, Jiang B, Garzon-Muvdi T, Caplan JM, Colby GP, Coon AL, Tamargo RJ, Huang J. The Effect of Flow-Related Aneurysms on Hemorrhagic Risk of Intracranial Arteriovenous Malformations. Neurosurgery. 2019 Oct 1;85(4):466-475. doi: 10.1093/neuros/nyy360.
PubMed 30107479Shakur SF, Amin-Hanjani S, Mostafa H, Charbel FT, Alaraj A. Hemodynamic Characteristics of Cerebral Arteriovenous Malformation Feeder Vessels With and Without Aneurysms. Stroke. 2015 Jul;46(7):1997-9. doi: 10.1161/STROKEAHA.115.009545. Epub 2015 May 19.
PubMed 25991417Kouznetsov E, Weill A, Ghostine JS, Gentric JC, Raymond J, Roy D. Association between posterior fossa arteriovenous malformations and prenidal aneurysm rupture: potential impact on management. Neurosurg Focus. 2014 Sep;37(3):E4. doi: 10.3171/2014.6.FOCUS14219.
PubMed 25175442Lv X, Wu Z, Jiang C, Yang X, Li Y, Sun Y, Zhang N. Angioarchitectural characteristics of brain arteriovenous malformations with and without hemorrhage. World Neurosurg. 2011 Jul-Aug;76(1-2):95-9. doi: 10.1016/j.wneu.2011.01.044.
PubMed 21839959
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Related to Rupture Flow-related Aneurysms in Posterior Arteriovenious Malformation: A Muti-center Observentional Research.
- ClinicalTrials.gov ID
- NCT07050381
- Acronym / sponsor ID
- pAVM-rFA / pAVM-rFA
- Conditions
- Arteriovenous Malformation of Central Nervous System, Aneurysm, Ruptured, Aneurysmatic Subarachnoid Haemorrhage, Aneurysm Cerebral
- Keywords
- arteriovenous malformation, flow-related aneurysm, ruptured aneurysm, subarachnoid hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2025 (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.
AVMs have been reported to rupture at a formidable annual rate of 2% to 3% at natural progression, often resulting in longterm neurological deficits and poor functional outcomes.The reported risk of hemorrhagic presentation in patients with AVMs is 41% to 65%. While many studies suggest a correlation between higher hemorrhage risk and the concurrent presence of AVM and aneurysms, few authors have focused specifically on flow-related aneurysms alone. In many instances, the source of rupture is also unclear. Meta-analysis from 2016 suggested that 49.2% of hemorrhages were secondary to aneurysm rupture, 45% from AVM rupture, and 5.7% were undetermined.In a study of 302 patients, of which 52.6% had a hemorrhagic presentation, demonstrated a significant increase in rate of hemorrhage in those with flow-related aneurysms. Thus, it is necessary to figure out risk factors related to ruptured flow-related aneurysms in pAVM.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pAVM with ruptured flow-related aneurysm | – | – |
| pAVM without ruptured flow-related aneurysm | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with posterior circulation malformations combined with ruptured or unruptured flow-related aneurysms will be included. Morphological data such as aneurysm size, location, parent artery, feeding arteries, draining vein count, malformation size, malformation location, and the ratio of malformation/aneurysm volume will be analyzed. These factors will be examined alongside medical histories of hypertension, diabetes, and coronary artery disease to investigate the risk factors for ruptured flow-related aneurysms.
Key inclusion criteria (2 listed)
- pAVM with flow-related aneurysms were identified by DSA, and subarachnoid hemorrhage was confirmed by CT
- No history of stroke, Marfan syndrome, polycystic kidney disease
Key exclusion criteria (2 listed)
- pAVM without flow-related aneurysms
- Absence of clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
characteristics of flow-related aneurysm
Time frame: From enrollment to the end of treatment at 8 weeks
size ratio(aneurysm depth (mm)/parent artery diameter (mm))
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 3 Jul 2025.
- Results publication: PubMed 30107479Hung AL, Yang W, Jiang B, Garzon-Muvdi T, Caplan JM, Colby GP, Coon AL, Tamargo RJ, Huang J. The Effect of Flow-Related Aneurysms on Hemorrhagic Risk of Intracranial Arteriovenous Malformations. Neurosurgery. 2019 Oct 1;85(4):466-475. doi: 10.1093/neuros/nyy360.
- Results publication: PubMed 25991417Shakur SF, Amin-Hanjani S, Mostafa H, Charbel FT, Alaraj A. Hemodynamic Characteristics of Cerebral Arteriovenous Malformation Feeder Vessels With and Without Aneurysms. Stroke. 2015 Jul;46(7):1997-9. doi: 10.1161/STROKEAHA.115.009545. Epub 2015 May 19.
- Results publication: PubMed 25175442Kouznetsov E, Weill A, Ghostine JS, Gentric JC, Raymond J, Roy D. Association between posterior fossa arteriovenous malformations and prenidal aneurysm rupture: potential impact on management. Neurosurg Focus. 2014 Sep;37(3):E4. doi: 10.3171/2014.6.FOCUS14219.
- Results publication: PubMed 21839959Lv X, Wu Z, Jiang C, Yang X, Li Y, Sun Y, Zhang N. Angioarchitectural characteristics of brain arteriovenous malformations with and without hemorrhage. World Neurosurg. 2011 Jul-Aug;76(1-2):95-9. doi: 10.1016/j.wneu.2011.01.044.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Malformation of Central Nervous System and Aneurysm, Ruptured, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
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 2 inclusion and 2 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Yifei Wang (+86-13852665323, wangyifei5323@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characteristics of flow-related aneurysm (time frame: From enrollment to the end of treatment at 8 weeks). 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 NCT07050381, which also lists 4 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 3 Jul 2025.