NCT07050381

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

February 10, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

arteriovenous malformationflow-related aneurysmruptured aneurysmsubarachnoid hemorrhage

Outcome Measures

Primary Outcomes (1)

  • characteristics of flow-related aneurysm

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

    From enrollment to the end of treatment at 8 weeks

Other Outcomes (5)

  • demographic information of pAVM-rFA

    From enrollment to the end of treatment at 8 weeks

  • demographic information

    From enrollment to the end of treatment at 8 weeks

  • characteristics of flow-related aneurysm

    From enrollment to the end of treatment at 8 weeks

  • +2 more other outcomes

Study Arms (2)

pAVM with ruptured flow-related aneurysm

pAVM without ruptured flow-related aneurysm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • pAVM without flow-related aneurysms
  • Absence of clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jiangsu Province Hospital

Nanjing, Jiangsu, 225500, China

ACTIVE NOT RECRUITING

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30107479BACKGROUND
  • 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.

    PMID: 25991417BACKGROUND
  • 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.

    PMID: 25175442BACKGROUND
  • 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.

    PMID: 21839959BACKGROUND

MeSH Terms

Conditions

Aneurysm, RupturedIntracranial AneurysmArteriovenous MalformationsSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 10, 2025

First Posted

July 3, 2025

Study Start

June 13, 2025

Primary Completion

August 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

July 3, 2025

Record last verified: 2025-06

Locations