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RecruitingNCT07050381pAVM-rFAUpdated Jul 3, 2025

The Risk Factors Related to Rupture Flow-related Aneurysms in Posterior AVM

An observational study in Arteriovenous Malformation of Central Nervous System, Aneurysm, Ruptured and Aneurysmatic Subarachnoid Haemorrhage, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 2 sites in China. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study 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%. 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.

02

Conditions studied

  • Arteriovenous Malformation of Central Nervous System
  • Aneurysm, Ruptured
  • Aneurysmatic Subarachnoid Haemorrhage
  • Aneurysm Cerebral

Keywords

  • arteriovenous malformation
  • flow-related aneurysm
  • ruptured aneurysm
  • subarachnoid hemorrhage
03

In context

Aneurysm, Ruptured

29 studies on the registry are indexed under Aneurysm, Ruptured; 7 are open to participants now.

This study's planned enrollment of 200 is close to the median of 183 across 12 observational studies indexed under Aneurysm, Ruptured.

Browse Aneurysm, Ruptured studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. pAVM with flow-related aneurysms were identified by DSA, and subarachnoid hemorrhage was confirmed by CT
  2. No history of stroke, Marfan syndrome, polycystic kidney disease

Exclusion criteria

Exclusion Criteria:

  1. pAVM without flow-related aneurysms
  2. Absence of clinical data
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • pAVM with ruptured flow-related aneurysm
  • pAVM without ruptured flow-related aneurysm
06

What researchers measure

Primary outcomes

  1. characteristics of flow-related aneurysm

    size ratio(aneurysm depth (mm)/parent artery diameter (mm))

    Time frame: From enrollment to the end of treatment at 8 weeks

Other outcomes

  1. demographic information of pAVM-rFA

    gender

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. demographic information

    age when be hospitalized

    Time frame: From enrollment to the end of treatment at 8 weeks

  3. characteristics of flow-related aneurysm

    aspect ratio (aneurysm depth (mm)/aneurysm neck (mm))

    Time frame: From enrollment to the end of treatment at 8 weeks

  4. characteristic of avm

    avm location

    Time frame: From enrollment to the end of treatment at 8 weeks

  5. characteristic of avm

    Spetzler-Martin grade of avm

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

1 of 2 sites recruiting
08

References and documents

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 30107479 ↗
  • Shakur 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 25991417 ↗
  • Kouznetsov 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 25175442 ↗
  • Lv 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Aug 2025, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2025
First posted
Jul 3, 2025
StartActual
Jun 13, 2025
Primary completionEst.
Aug 31, 2025
CompletionEst.
Dec 31, 2026
Last update
Jul 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07050381
Responsible party
Lu Hua (professor, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Jul 3, 2025
Start date
Jun 13, 2025
Primary completion
Aug 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 3, 2025

Study contacts

Yifei Wang
Contact
wangyifei5323@163.com
+86-13852665323

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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