NCT03940859

Brief Summary

This study will evaluate the feasibility to predict the prognosis of IDA with IMH by DCE-MRI and provide theoretical basis for the prognosis and intervention of the disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

May 5, 2019

Last Update Submit

July 17, 2019

Conditions

Dissecting Aneurysm of Cerebral Artery

Keywords

contrast-enhanced magnetic resonance imagingintracranial dissecting aneurysmintramural hematomaprognosis

Outcome Measures

Primary Outcomes (1)

  • neovascularization and permeability factors related to enlargement of IMH as assessed by DCE-MRI.

    Using DCE-MRI, the parameters as Ktrans and Vp could be calculated and analyzed. These will be studied as a composite indicator for the enlargement of IMH.

    6 months

Secondary Outcomes (1)

  • clinical factors related to the enlargement of IMH as recorded from medical chart

    6 months

Study Arms (1)

DEMAT

Patients with intramural hematoma in intracranial dissecting aneurysm treated by endovascular treatment will be recruited.

Device: intracranial stent, flow diverter and coils

Interventions

intracranial stent, flow diverter and coilsDEVICE

Endovascular treatment was performed under general anesthesia. Patients were treated with internal trapping, stent-assisted coiling or flow diverter as appropriate. After the procedure, patients treated with conventional stent were given 75mg/d clopidogrel for 6 weeks and 100mg/d aspirin for 6months, while patients treated with flow diverter were given 75mg/d clopidogrel for 3 months and 100mg/d aspirin thereafter. All patients were recommended to undergo a 6-month angiographic follow-up.

Also known as: Low profile Visualized Intraluminal Device (LVIS), Pipeline™(or Flex) Embolization Device(PED)
DEMAT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients had an IDA with IMH and received an endovascular treatment.

You may qualify if:

  • adult patients (age 18-80 years) patients' ability to cooperate during the MRI examination; patients who are were diagnosed with IDA according to DSA and MRI; expectation of adequate patient safety during these examinations; unequivocal evidence by MRI (IMH\>5 mm on the perpendicular plane to the long axis of the vessel) of IDA; IDA treated by the endovascular approach; patients' willingness to participate in the study.

You may not qualify if:

  • patients with pre-existing diagnoses of arteritis, fibromuscular dysplasia, iatrogenic aneurysms or pseudoaneurysms; extracranial dissecting aneurysms extended into the intracranial segment; patients with other diseases or poor general condition with expected survival of less than 2 year; the IDA has already been treated by the endovascular treatment; patients lacking DCE-MRI follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

  • Tian Z, Wang Z, Li W, Zhu W, Liu J, Zhang Y, Yang X, Zhang Y. Dynamic contrast-enhanced MRI analysis for prognosis of intracranial dissecting aneurysm with intramural haematoma after endovascular treatment: an observational registry study. Stroke Vasc Neurol. 2021 Mar;6(1):133-138. doi: 10.1136/svn-2020-000326. Epub 2020 Jul 1.

    PMID: 32611729DERIVED

Central Study Contacts

Yisen Zhang, Dr.

CONTACT

+86-010-59978852zhang-yisen@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Doctor of Department of Interventional Neuroradiology

Study Record Dates

First Submitted

May 5, 2019

First Posted

May 7, 2019

Study Start

June 1, 2019

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

CN(1)