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Treatment of Ruptured Intracranial Aneurysms in China.

2018年10月2日 更新者：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.

調査の概要

状態

わからない

条件

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

1384

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国、510282
        • Southern medical university, zhujiang hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

14年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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；

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
The safety evaluation of interventional therapy and craniotomy clipping.
時間枠：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.
時間枠：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 ).
時間枠：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.
時間枠：1 year.
  1. Complete occlusion
  2. Partial occlusion
  3. Recurrence.
1 year.
The effectiveness evaluation of craniotomy clipping.
時間枠：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.
時間枠：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.
時間枠：6 months later after operation.
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
6 months later after operation.

二次結果の測定

結果測定
メジャーの説明
時間枠
The safety evaluation interventional therapy.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：3 months.
3 months.
The incidence of major adverse events in 3 months and 6 months later after operation.
時間枠：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.
時間枠：6 months and 12 months later after operation.
6 months and 12 months later after operation.
The safety evaluation of craniotomy clipping.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：12 months later after operation.
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
12 months later after operation.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Zhujiang Hospital

協力者

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

捜査官

  • 主任研究者：Xuying He, PH. D、Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2018年11月1日

一次修了 (予想される)

2020年5月31日

研究の完了 (予想される)

2020年5月31日

試験登録日

最初に提出

2018年2月7日

QC基準を満たした最初の提出物

2018年3月8日

最初の投稿 (実際)

2018年3月12日

学習記録の更新

投稿された最後の更新 (実際)

2018年10月3日

QC基準を満たした最後の更新が送信されました

2018年10月2日

最終確認日

2018年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2016YFC1300800

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

investigators can share the original data 5 years after the study

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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