Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04927520 |
| Other study ID # |
2019-174 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 5, 2021 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
June 2021 |
| Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Contact |
Xu Jing |
| Phone |
+86-13958119687 |
| Email |
jingxu[@]zju.edu.cn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Intracranial aneurysm is one of the most common cerebrovascular diseases, with a prevalence
of about 3.2%. With the aging of the population and the further popularization of MRA and
other examination methods, the prevalence of intracranial aneurysm will further increase.
Rupture of intracranial aneurysm is an important cause of death and severe disability in
patients. The annual rate of rupture of intracranial aneurysm is about 1%, and the size of
aneurysm, the location of aneurysm in the posterior circulation, and the history of
subarachnoid hemorrhage on the aneurysm wall are the risk factors for aneurysm rupture.
Phases are currently recognized tools for assessing the risk of aneurysm rupture, which can
provide important guidance for neurosurgeons and patients to decide whether to actively
intervene. In the last century, for patients with intracranial aneurysm with high risk of
rupture, craniotomy and clipping for intracranial aneurysm was the gold standard for
treatment.
However, with the rapid development of embolization technology and materials in the past 20
years, the application of endovascular embolization for intracranial aneurysms has been more
and more widely, especially after several large prospective studies such as ISAT and ISUIA,
endovascular embolization has more advantages over craniotomy clipping.Whereas, it is still
very popular to adopt craniotomy clipping for middle cerebral artery aneurysms, the main
reasons for which are relative superficial location, wider aneurysm neck, smaller parent
artery and more branching vessels, etc., which make early endovascular embolization treatment
not advantageous. With the maturity of stent-assisted embolization technology in recent
years, the use of a new generation of stents, and the improvement of perioperative
anti-platelet strategies, endovascular embolization has achieved good results in the
treatment of middle artery aneurysms. However, these studies were retrospective,
single-center studies, subject to a variety of confounding factors, and the reliability of
the results is limited.
Therefore, it will be of great clinical significance to carry out a prospective, multi-center
clinical study on the treatment strategy of middle cerebral artery aneurysms.
Patients with unruptured middle cerebral artery aneurysms who had been diagnosed with at
least one imaging （CTA/MRA/DSA）were enrolled. The treatment including endovascular
embolization and craniotomy clipping was determined according to routine management in the
center. After receiving informed consent from the patients, the safety and effectiveness data
were obtained to verify whether endovascular embolization was safe and effective. Through
further follow-up and data analysis, protective factors and risk factors for the treatment of
middle cerebral artery aneurysms were investigated. Through well-designed clinical studies,
safer and more effective treatment methods can be found, and potential factors leading to
perioperative complications can be found, ultimately improving the prognosis of patients with
middle cerebral artery aneurysms.
Description:
1. Data collection and management A unified and open public health platform will be
established, and data will be centrally recorded in each central unit for verification
by inspectors. An open network data platform for intracranial aneurysm research was
established by the management personnel of different qualification levels. In order to
ensure the advancement and sustainable development of the data platform construction, a
public research platform for intracranial aneurysms shared in the province was built by
using the keywords and retrieval items commonly used in China.
After researcher training and standardized study of the scheme, the formal trial was
started. A team of experts will be selected to form an inspection team, which will
initiate visits to each organization and conduct the first inspection visit as soon as
possible after screening the first subject. Regular monitoring visits are required until
the end of the experiment. All the data were collected according to the electronic
medical record (CRF) form, and then the aneurysm data (EDC) was managed according to the
CRF form, and the accuracy and rigor of the data were checked in time.
This study establishes a management committee, including clinical experts,
evidence-based medicine experts, and CRO clinical study supervisors, who are responsible
for project design, task formulation, supervision of project implementation, data
analysis and formulation of standards and guidelines.
The central laboratory and imaging interpretation center were established to carry out
unified standard central storage for clinical specimens. The unified image and
laboratory technology platform can be used for the image examination and post-processing
technology in the project. Uniform standard interpretation of imaging data was carried
out. A unified, standardized and efficient transmission mechanism for clinical
specimens, data and data in each center was established.
Establish a data management committee, set up a network data platform and be responsible
for the construction and maintenance of the database, conduct real-time supervision on
the quality of the input data, ensure the safety, integrity and accuracy of the data,
establish and organize the implementation of the platform or offline dual-channel error
correction and reminder mechanism. Set and manage the rights of all project participants
on the data platform, monitor and record the data entry, modification and retrieval, set
and manage the data publication of the open platform. Contact and consult statistical
experts to conduct periodic analysis of data results and generate research reports.
Relying on professional CRO company, in the implementation process for the
implementation of the progress and quality of the implementation of random inspection
supervision. At the same time, set up a data regular self-check mechanism. Establish a
mechanism for regular training and evaluation of research participants. During the
research progress, regular project coordination meetings were held to timely coordinate
and solve problems in the process of the project.
2. Sample size Sample size was calculated according to a calculation formula (α=0.05,
bilateral test, 80% assurance). According to the literature and the data of the center,
the rate of MRS<2 at 3 months was 95% for patients with endovascular interventional, and
was 85% for those with craniotomy and clipping. The number of samples needed for each
group was calculated by the software PASS15 to be at least 141. Considering that the
maximum shedding rate of 20% might occur during the clinical follow-up, 180 cases were
needed for each group, and 360 subjects were finally decided to be included in the
study.
3. Statistical Methods Statistical analysis of planned primary and secondary study
endpoints will be conducted in accordance with the intentionality treatment principle.
Subgroup analysis According to the needs of the experiment, the subjects can be divided
into different centers, male and female, and different age groups for corresponding
subgroup analysis. Methods for processing lost data Statistical analysis did not follow
the study protocol population definition and other statistical methods were used to deal
with lost data (e.g. multiple interpolation).
4. Ethical approval of clinical research projects The study plan was reviewed and approved
by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University School
of Medicine. The study protocol was designed and implemented in accordance with the
International Conference on Harmonization for Good Clinical Practice (ICH-GCP)
guidelines. In line with the national ethical behavior requirements, applicable to local
laws and regulations, in strict compliance with the World Medical Association (WMA)
Declaration of Helsinki ethical provisions.
5. Informed Consent Process Improve the relevant examinations, check the inclusion and
exclusion criteria of patients, and send the detailed information of the study to
patients or their legal clients. If the patients or legal clients agree to participate
in the study, they need to sign two copies of informed consent. The original consent
form should be kept in the patient's study folder and another copy given to the patient.
Patients or legal clients have the right to terminate their participation in the study
at any time, and their decision will be recorded in the patient's study record.
6. confidentiality The investigators will take every step to respect the privacy of the
participants in the study. Only data that does not contain identifying information will
be entered into the central research database to ensure the privacy of participants. In
the process of monitoring data quality and study protocol compliance, the data monitor
will refer to the medical records of the subject's clinical center and record them on
the patient information sheet. In the reporting data and results, all personal
information and research center information will be hidden to protect the privacy of
participants.
7. Adverse events management Adverse events occurred in the process of adverse events
refers to the study of the subjects has a harmful effect on the health of all events.
Serious Adverse Event Category: Serious Adverse Event refers to any event that occurred
during the course of the study that had a serious adverse effect on the health of the
subjects. Include: cause the subject to be hospitalized, prolong the length of the
subject's hospital stay, cause the subject to be disabled, cause the subject's
neurological or physical dysfunction, cause the subject's offspring to be born with a
deformity, endanger the subject's life, the subject's death or other events that have a
serious adverse effect on the subject's health. Adverse events reported to process all
kinds of adverse events: take timely measures to deal with, and recorded in a report on
the case. Serious adverse event (SAE) : take timely measures to deal with, and recorded
in a report on the case, the researchers decided to withdrawal or by drugs, immediately
report ethics committee, the drug clinical trial institution and the sponsor, 24 hours,
report to the national and provincial food and drug administration. SAE is required to
report adverse events and proximate errors via the Intra-hospital Network Notification
System.
