Dissecting Aneurysm of Cerebral ArteryDEMATNCT03940859
Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis for Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment
An observational study of Dissecting Aneurysm of Cerebral Artery, run by Beijing Neurosurgical Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dissecting Aneurysm of Cerebral Artery
- What is being tested?
- intracranial stent, flow diverter and coils
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Dec 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: All patients had an IDA with IMH and received an endovascular treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Yisen Zhang, Dr., +86-010-59978852, zhang-yisen@163.com
About this study
Official title: Investigation of Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis Predicting Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment
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.
Read the 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.
- Conditions
- Dissecting Aneurysm of Cerebral Artery
- Being tested
- intracranial stent, flow diverter and coils
- Keywords
- contrast-enhanced magnetic resonance imaging, intracranial dissecting aneurysm, intramural hematoma, prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracranial stent, flow diverter and coilsDevice
Also called Low profile Visualized Intraluminal Device (LVIS), Pipeline™(or Flex) Embolization Device(PED)
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.
| Study group | Role | What they receive |
|---|---|---|
| DEMAT | Patients with intramural hematoma in intracranial dissecting aneurysm treated by endovascular treatment will be recruited. Receives: Device: intracranial stent, flow diverter and coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
clinical factors related to the enlargement of IMH as recorded from medical chart
size, treatment method, device use, follow-up interval, smoke history, hypertension, et al, will be recorded and analyzed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Jun 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dissecting Aneurysm of Cerebral ArteryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhangyisen, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940859
- Sponsor's protocol ID
- NSFC-81801158
- Acronym
- DEMAT
- Status last verified
- Jul 2019
- First submitted
- 5 May 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32611729
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis Predicting Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment
- ClinicalTrials.gov ID
- NCT03940859
- Acronym / sponsor ID
- DEMAT / NSFC-81801158
- Conditions
- Dissecting Aneurysm of Cerebral Artery
- Keywords
- contrast-enhanced magnetic resonance imaging, intracranial dissecting aneurysm, intramural hematoma, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 May 2019 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEMAT | – | Device: intracranial stent, flow diverter and coilsPatients with intramural hematoma in intracranial dissecting aneurysm treated by endovascular treatment will be recruited. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients had an IDA with IMH and received an endovascular treatment.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracranial stent, flow diverter and coilsAlso: Low profile Visualized Intraluminal Device (LVIS), Pipeline™(or Flex) Embolization Device(PED)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. | Device | DEMAT |
Primary outcome
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.
1 secondary outcome
clinical factors related to the enlargement of IMH as recorded from medical chart
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Derived from this study: PubMed 32611729Tian 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.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dissecting Aneurysm of Cerebral Artery, run by Beijing Neurosurgical Institute at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yisen Zhang, Dr. (+86-010-59978852, zhang-yisen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neovascularization and permeability factors related to enlargement of IMH as assessed by DCE-MRI. (time frame: 6 months). 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 NCT03940859, which also lists 1 linked publication.
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 18 Jul 2019.