Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04927520
Status:
RECRUITING
Last Update Posted:
2021-06-16
First Post:
2021-06-05
Brief Title:
Prospective Multicenter Cohort Study on the Safety and Efficacy of Treatment for Middle Cerebral Artery Aneurysms
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Safety and Efficacy of Treatment for Middle Cerebral Artery Aneurysms a Prospective and Multicenter Trial
Status:
RECRUITING
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intracranial aneurysm is one of the most common cerebrovascular diseases with a prevalence of about 32 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 clippingWhereas 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 CTAMRADSAwere 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
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 clippingWhereas 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 CTAMRADSAwere 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
Detailed 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 α005 bilateral test 80 assurance According to the literature and the data of the center the rate of MRS2 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 eg 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 patients 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 patients 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 subjects 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 subjects hospital stay cause the subject to be disabled cause the subjects neurological or physical dysfunction cause the subjects offspring to be born with a deformity endanger the subjects life the subjects death or other events that have a serious adverse effect on the subjects 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
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 α005 bilateral test 80 assurance According to the literature and the data of the center the rate of MRS2 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 eg 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 patients 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 patients 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 subjects 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 subjects hospital stay cause the subject to be disabled cause the subjects neurological or physical dysfunction cause the subjects offspring to be born with a deformity endanger the subjects life the subjects death or other events that have a serious adverse effect on the subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None