Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis for Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment (DEMAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940859
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
zhangyisen, Beijing Neurosurgical Institute

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.

Condition or disease Intervention/treatment
Dissecting Aneurysm of Cerebral Artery Device: intracranial stent, flow diverter and coils

Detailed Description:

Intracranial dissecting aneurysm (IDA) was a challenging disease and could result in stroke in young and middle-aged adults. Intramural hematoma, one of the typical imaging findings of IDA, can grow continuously in untreated IDA. Due to relatively high complication rate associated with surgical procedures, endovascular treatments have become the first-line therapy for such lesions. According to whether the parent artery was maintained, endovascular treatment was divided into deconstructive (proximal arterial occlusion and internal trapping) and reconstructive (stent implantation with or without coiling) techniques . However, recanalization of IDA was a great challenge for endovascular treatment and influenced the prognosis of patients.

The formation of an IMH is a critical event in the progress of IDA and IDA may grow because of recurrent IMH even after deconstructive endovascular treatment. Increased IMH size could result in severe compression symptoms or even death. At present, the mechanism of the continuous growth of intramural hematoma after endovascular treatment of IDA is still unclear. Some authors believe that the continuous hemorrhage of the vasa vasorum in the IMH results in the continuous enlargement of the IMH. However, this theory has not been proved by imaging in vivo.

Dynamic contrast-enhanced magnetic resonance imaging analysis for prognosis of intracranial dissecting aneurysm with intramural hematoma after endovascular treatment (DEMAT) is a prospective trial designed to collect a large series of patients with IDAs treated endovascularly to predict the prognosis of IDA with IMH by DCE-MRI and provide theoretical basis for the prognosis and intervention of the disease.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Investigation of Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis Predicting Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms MRI Scans

Group/Cohort Intervention/treatment
DEMAT
Patients with intramural hematoma in intracranial dissecting aneurysm treated by endovascular treatment will be recruited.
Device: intracranial stent, flow diverter and coils
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.
Other Names:
  • Low profile Visualized Intraluminal Device (LVIS)
  • Pipeline™(or Flex) Embolization Device(PED)




Primary Outcome Measures :
  1. neovascularization and permeability factors related to enlargement of IMH as assessed by DCE-MRI. [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. clinical factors related to the enlargement of IMH as recorded from medical chart [ Time Frame: 6 months ]
    size, treatment method, device use, follow-up interval, smoke history, hypertension, et al, will be recorded and analyzed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients had an IDA with IMH and received an endovascular treatment.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940859


Contacts
Layout table for location contacts
Contact: Yisen Zhang, Dr. +86-010-59978852 zhang-yisen@163.com

Locations
Layout table for location information
China, Beijing
Beijing Neurosurgical Institute and Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100070
Contact: Yisen Zhang, Dr.    +86-010-59978852    zhang-yisen@163.com   
Sponsors and Collaborators
Beijing Neurosurgical Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: zhangyisen, Attending Doctor of Department of Interventional Neuroradiology, Beijing Neurosurgical Institute
ClinicalTrials.gov Identifier: NCT03940859    
Other Study ID Numbers: NSFC-81801158
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by zhangyisen, Beijing Neurosurgical Institute:
contrast-enhanced magnetic resonance imaging
intracranial dissecting aneurysm
intramural hematoma
prognosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aneurysm, Dissecting
Hematoma
Vascular Diseases
Cardiovascular Diseases
Hemorrhage
Pathologic Processes