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Treatment of Ruptured Intracranial Aneurysms in China.

2018년 10월 2일 업데이트: He xuying, Zhujiang Hospital

The Safety and Efficacy of Ruptured Intracranial Aneurysms Embolized Assisted With Stents（SERIAES）.

Ruptured intracranial aneurysms is currently a common disease that seriously affects human health and quality of life due to its high morbidity,high mortality and high disability. At present,Ruptured intracranial aneurysms are treated with craniotomy clipping and interventional embolization ,but for ruptured wide-neck intracranial aneurysms, the treatment of craniotomy clipping and coiling embolization are not effective.With the improvement of endovascular treatment materials and techniques, three dimensional coil basket technique, double microcatheter technique, balloon assisted ONYX embolization, simple stent covered aneurysm neck, balloon or stent assisted neck remodeling and coil embolization are used in endovascular treatment of ruptured wide-neck intracranial aneurysms. The treatment methods are different in the intervention effect of ruptured wide-neck intracranial aneurysms, for example, the complications of interventional therapy are lower than craniotomy clipping,but the rate of well functional outcome (mRS ≤2) differed significantly by 3 months follow-up (65.0% vs.75.0%), and there is not standard of treatment in different parts of ruptured wide-neck intracranial aneurysms in our country, the choice of interventional therapy or craniotomy clipping are different in different clinical centers; on the other hand, there are serious problems in the treatment of ruptured wide-neck intracranial aneurysms, because without the relevant guidelines of diagnosis and treatment of ruptured wide-neck intracranial aneurysms, different clinical centers will cause excessive treatment of ruptured wide-neck intracranial aneurysms, not only bring unreasonable utilization of medical resources, but also cause the subject's life and property to be threatened.

The patients with ruptured wide-neck intracranial aneurysms(n=1084) and unruptured intracranial aneurysms(n=300) were included in prospective cohort study, after interventional therapy and craniotomy clipping, setting fixed time for postoperative follow-up, the clinical data and image data were recorded, the safety, efficacy and economic benefits of interventional treatment and craniotomy clipping were compared, providing strategies for the standardized treatment of ruptured wide-neck intracranial aneurysms.

연구 개요

상태

알려지지 않은

정황

상세 설명

For this study, investigators consulted and hired professionals and experts about data collection, data and methodology, including Data Monitoring Committee, Data Management Committee, Project Academic Committee,Executive Group Project Manager, Project Statistician, Technical Support Center, investigators have a scientific regulations for this project, Project Manager and Executive Group: To ensure the successfully implementation of this project, including charging the daily operations of the study in 6 different research hospitals, organizing the monthly meeting to consider issues raised during the monthly progress of the study, liaising with the steering committee the data management center and statistical center , Data management Committee: To be responsible for setting up and maintain the Electronic Data Capture(EDC) System according to the paper case Report Form (pCRF) designed by principal investigators. To collect and save the pCRF coming from sub-centers. To entry the data into EDC system and keep the same with CRF. To organize training for the investigators about the rules in filling the EDC and pCRF.To determine the frequency of the Data Management Report and to fed it back to the steering committee every three months, Data Monitoring Committee: To determine the frequency of the data monitoring including the source data(Medical records) accuracy, completeness and representativeness comparing the external data(EDC,pCRF） in 12 centers.To report the results after the monitoring back to the steering committee about the missing data, non-reported and other problems about the study. To make a Standard Operation Procedure (SOP) from getting data to using data. Academic Committee: To supervise the academic issues including patient recruitment, protocol deviation, adverse events evaluating. To settle down the question and problem in the process of the study, Project Statistician: We cooperate with the Statisticians of Medical Research & Biometrics center National Center for Cardiovascular Diseases, China ti get the professional statistical report. Technical Support Center: To provide technical support during the process of the study.

연구 유형

관찰

등록 (예상)

1384

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Wenxian Zeng, M.D
  • 전화번호: +86-013926290871
  • 이메일: 602057619@qq.com

연구 연락처 백업

  • 이름: Xifeng Li, PH. D
  • 전화번호: +86-018620993755
  • 이메일: nflxf@126.com

연구 장소

  • 중국
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510282
        • Southern Medical University, Zhujiang Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Xuying He, PH. D
        • 부수사관:
          • Wenxian Zeng, M.D
        • 부수사관:
          • Xin Zhang, PH. D
        • 부수사관:
          • Xifeng Li, PH. D

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

14년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Patients with ruptured intracranial aneurysms and un-ruptured intracranial aneurysms.

설명

Inclusion Criteria:

  1. At least one imaging methods( CTA/ MRA/DSA ) confirmed ruptured wide-neck intracranial aneurysms (fundus-to-neck ratio < 2 or neck diameter > 4 mm );
  2. Stent-Assisted Coiling of un-ruptured intracranial aneurysms, whether have clinical symptoms or no;
  3. For multiple aneurysms, regardless of previous treatment, the requirement for treatment interval should >6 months;
  4. The subjects age 14 years;
  5. subjects or family members agree to sign informed consent.

Exclusion Criteria:

  1. Subjects with other intracranial vascular malformations, such as AVM, AVF. Etc;
  2. Subjects with malignant tumors in the intracranial or other parts of the body;
  3. Fusiform, traumatic, bacterial or dissecting aneurysm;
  4. Subjects with severe mental illness unable to communicate when diagnosing disease;
  5. The body condition is poor, the survival time is less than 1 year or poor physical condition, cannot tolerate the general anesthesia or aneurysm surgery;
  6. Subjects involved in other intracranial aneurysms related clinical research;
  7. A patient who received surgical clipping or endovascular treatment at once;
  8. Subjects who were not followed up；

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The safety evaluation of interventional therapy and craniotomy clipping.
기간: 6 months later after operation.
2.The safety evaluation including the mortality(mRS=6) rate and disability(3<mRS<6) rate of subjects.
6 months later after operation.
The safety evaluation of interventional therapy and craniotomy clipping.
기간: 6 months later after operation.
The safety evaluation including the mortality(mRS=6) rate of subjects.
6 months later after operation.
Modified Rankin score ( mRS ).
기간: 1 year.

0. completely silent.

  1. despite symptoms, but not visibly disabled, can complete all regular duties and activities
  2. mild disabilities, not all activities previously possible, but can deal with personal affairs without need of assistance
  3. moderate disability requires some help, but walking does not need assistance
  4. severe disabilities, unable to walk independently, no others can not meet their needs
  5. severely disabled, bedridden, Urine, requiring continuous care and care
  6. mortality.
1 year.
Raymond classification.
기간: 1 year.
  1. Complete occlusion
  2. Partial occlusion
  3. Recurrence.
1 year.
The effectiveness evaluation of craniotomy clipping.
기간: 6 months later after operation.
The effectiveness evaluation including the complete occlusion( Raymond classification=1) rate of aneurysms.
6 months later after operation.
The effectiveness evaluation of interventional treatment.
기간: 6 months later after operation.
The effectiveness evaluation including the recurrence ( Raymond classification =3) rate of aneurysms.
6 months later after operation.
The effectiveness evaluation of craniotomy clipping.
기간: 6 months later after operation.
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
6 months later after operation.

2차 결과 측정

결과 측정
측정값 설명
기간
The safety evaluation interventional therapy.
기간: 12 months later after operation.
The safety evaluation including the mortality( mRS=6)rate and disability(3<mRS<6 ) rate of subjects.
12 months later after operation.
The effectiveness evaluation of interventional treatment.
기간: 12 months later after operation.
The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.
12 months later after operation.
The success rate of treatment.
기간: 6 months later after operation.
Angiography revealed total or near total occlusion of aneurysm in 6 months after operation, no recurrence of aneurysm was found. the treatment was considered successful.
6 months later after operation.
The incidence of major adverse events after 3 months of surgery.
기간: 3 months.
3 months.
The incidence of major adverse events in 3 months and 6 months later after operation.
기간: 3 months and 6 months later after operation.
3 months and 6 months later after operation.
The incidence of major adverse events in 6 months and 12 months later after operation.
기간: 6 months and 12 months later after operation.
6 months and 12 months later after operation.
The safety evaluation of craniotomy clipping.
기간: 12 months later after operation.
The safety evaluation including the mortality( MRS=6 ) rate and disability(3<MRS <6) rate of subjects.
12 months later after operation.
The effectiveness evaluation of interventional treatment.
기간: 12 months later after operation.
The effectiveness evaluation including the recurrence( Raymond classification=3 ) rate of aneurysms.
12 months later after operation.
The effectiveness evaluation of craniotomy clipping.
기간: 12 months later after operation.
The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.
12 months later after operation.
The effectiveness evaluation of craniotomy clipping.
기간: 12 months later after operation.
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
12 months later after operation.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Zhujiang Hospital

협력자

Second Affiliated Hospital, School of Medicine, Zhejiang University
Xuanwu Hospital, Beijing
The First Affiliated Hospital of Zhengzhou University
Air Force Military Medical University, China
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Nanchang University
First Affiliated Hospital of Harbin Medical University

수사관

  • 수석 연구원: Xuying He, PH. D, Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2018년 11월 1일

기본 완료 (예상)

2020년 5월 31일

연구 완료 (예상)

2020년 5월 31일

연구 등록 날짜

최초 제출

2018년 2월 7일

QC 기준을 충족하는 최초 제출

2018년 3월 8일

처음 게시됨 (실제)

2018년 3월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 10월 2일

마지막으로 확인됨

2018년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2016YFC1300800

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

investigators can share the original data 5 years after the study

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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