|
|
 Promotion Meeting
DIRECT-MT Promotion Meeting was successfully held in Shanghai！
On Mar 31, 2018, we held the DIRECT-MT Promotion Meeting · East China in Shanghai.
The DIRECT-MT project has been initiated in 6 sites within 3 weeks after March!
The DIRECT-MT Promotion Meeting was held in Linyi.
On April 15, we held the DIRECT-MT Promotion Meeting · Shandong by the side of Yi River in Linyi City.
The DIRECT-MT project is initiated in 4 sites in the first half of April! Thank all investigators for their active support!
The study is estimated to be initiated in 9 sites in the next half month. At present, 46 sites across the country participate in the DIRECT-MT study. We plan to complete all initiations in the first half of this year. We are looking forward to support from all investigators!
The DIRECT-MT Promotion Meeting was held in Zhengzhou.
On April 22, we held the DIRECT-MT Promotion Meeting · Henan & Hebei in the ancient city of Central Plains - Zhengzhou.
The DIRECT-MT project is initiated in 5 sites in the second half of April!
The study is estimated to be initiated in 4 sites in the next two weeks. At present, 46 sites across the country participate in the DIRECT-MT study. We plan to complete all initiations in the first half of this year. We are looking forward to support from all investigators!
At present, 24 subjects have been enrolled! Thank all investigators for their hard work!
Based on this progress, it is hopeful to enroll 540 subjects ahead of schedule. It is reemphasized that the DIRECT-MT study adopts competitive enrollment, so all investigators are required to positively carry out enrollment work. Thank you!
The DIRECT-MT Promotion Meeting was held in Chongqing.
On May 13, we held the DIRECT-MT Promotion Meeting · Southwest, South & Central China in the beautiful mountain city - Chongqing.
The DIRECT-MT project is initiated in 5 sites in the second half of April!
The study is estimated to be initiated in 4 sites in the next two weeks. At present, 46 sites across the country participate in the DIRECT-MT study. We plan to complete all initiations in the first half of this year. We are looking forward to support from all investigators!
At present, 24 subjects have been enrolled! Thank all investigators for their hard work!
Based on this progress, it is hopeful to enroll 540 subjects ahead of schedule. It is reemphasized that the DIRECT-MT study adopts competitive enrollment, so all investigators are required to positively carry out enrollment work. Thank you!
DIRECT-MT Promotion Meeting was successfully held in Changchun！
On Mar 31, 2018, we held the DIRECT-MT Promotion Meeting ·Northeast China in Changchun.
Initiation Meeting
DIRECT-MT was successfully launched at Changhai Hospital!
DIRECT-MT was launched successfully at the leading institution of the project, Changhai Hospital of the Second Military Medical University, on January 30, 2018.
DIRECT-MT was successfully initiated at Taizhou First People's Hospital!
After launch in Changhai Hospital, DIRECT-MT was successfully initiated at Taizhou First People's Hospital on Mar 14, 2018.
DIRECT-MT was initiated at Guangzhou Overseas Chinese Hospital!
On Mar 15, 2018, Guangzhou Overseas Chinese Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at Baotou Central Hospital!
On Mar 21, 2018, Baotou Central Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at Nanning Second People's Hospital!
On Mar 23, 2018, Nanning Second People's Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at Yantaishan Hospital!
On Mar 28, 2018, Yantaishan Hospital held DIRECT-MT initiation meeting.
Initiation Meeting at Affiliated Hospital of Nantong University!
On Mar 30, 2018, Affiliated Hospital of Nantong University held DIRECT-MT initiation meeting.
Initiation Meeting at The First People's Hospital of Changzhou!
On Apr 3, 2018, The First People's Hospital of Changzhou initiated the DIRECT-MT.
Initiation Meeting at Luoyang Central Hospital Affiliated to Zhengzhou University!
On Apr 4, 2018, initiation meeting of the DIRECT-MT was successfully held at Luoyang Central Hospital Affiliated to Zhengzhou University.
DIRECT-MT was initiated at Chongqing Three Gorges Central Hospital!
On Apr 12, 2018, Chongqing Three Gorges Central Hospital held DIRECT-MT initiation meeting.
Initiation Meeting at Linyi People's Hospital!
On Apr 16, 2018, initiation meeting of the DIRECT-MT was successfully held at Linyi People's Hospital.
DIRECT-MT was initiated at The First Affiliated Hospital of Soochow University!
On Apr 17, 2018, initiation meeting of the DIRECT-MT was successfully held at The First Affiliated Hospital of Soochow University.
DIRECT-MT was initiated at The Second Affiliated Hospital to Henan University of Science and Technology!
The initiation meeting of the DIRECT-MT was successfully held at The Second Affiliated Hospital to Henan University of Science and Technology on Apr 18, 2018.
DIRECT-MT was initiated at Liaocheng People's Hospital!
On Apr 19, 2018, initiation meeting of the DIRECT-MT was successfully held at Liaocheng People's Hospital.
DIRECT-MT was initiated at Wenzhou Central Hospital!
The initiation meeting of the DIRECT-MT was successfully held at Wenzhou Central Hospital on Apr 23, 2018.
DIRECT-MT was initiated at Zhangzhou Affiliated Hospital of Fujian Medical University!
On Apr 26, 2018, initiation meeting of the DIRECT-MT was successfully held at Zhangzhou Affiliated Hospital of Fujian Medical University.
DIRECT-MT was initiated at The First Hospital of Hebei Medical University!
The initiation meeting of the DIRECT-MT was successfully held at The First Hospital of Hebei Medical University on May 3, 2018.
DIRECT-MT was initiated at Ningbo First Hospital!
The initiation meeting of the DIRECT-MT was successfully held at Ningbo First Hospital on May 11, 2018.
DIRECT-MT was initiated at Qingdao Center Hospital!
The initiation meeting of the DIRECT-MT was successfully held at Qingdao Center Hospital on May 16, 2018.
DIRECT-MT was initiated at Binhai Hospital & Daping Hospital!
The initiation meeting of the DIRECT-MT was successfully held at Binhai Hospital & Daping Hospital on May 17, 2018.
DIRECT-MT was initiated at The Second Affiliated Hospital of Zhejiang University!
The initiation meeting of the DIRECT-MT was successfully held at The Second Affiliated Hospital of Zhejiang University on May 18, 2018.
DIRECT-MT was initiated at Zhoukou Central Hospital!
The initiation meeting of the DIRECT-MT was successfully held at Zhoukou Central Hospital on May 20, 2018.
DIRECT-MT was initiated at Nanjing Drum Tower Hospital!
The initiation meeting of the DIRECT-MT was successfully held at Nanjing Drum Tower Hospital on May 23, 2018.
DIRECT-MT was initiated at First Affiliated Hospital of Anhui Medical University & Nanjing First Hospital!
The initiation meeting of the DIRECT-MT was successfully held at First Affiliated Hospital of Anhui Medical University & Nanjing First Hospital on May 30, 2018.
DIRECT-MT was initiated at Tangdu Hospital!
On Jun 1, 2018, Tangdu Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at Sichuan Provincial Hospital!
On Jun 7, 2018, Sichuan Provincial Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at Zhuhai People's Hospital!
On Jun 8, 2018, Zhuhai People's Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at Anhui Provincial Hospital!
On Jun 14, 2018, Anhui Provincial Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at The Affiliated Hospital of Guizhou Medical University!
On Jun 21, 2018, The Affiliated Hospital of Guizhou Medical University held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at The First Bethune Hospital of Jilin University!
On Jun 24, 2018, DIRECT-MT initiation meeting was held at The First Bethune Hospital of Jilin University.
DIRECT-MT was initiated at Maoming People's Hospital!
On Jun 27, 2018, Maoming People's Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at The First People's Hospital of Hangzhou!
On Jun 28, 2018, The First People's Hospital of Hangzhou held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at Hebei General Hospital!
On Jul 4, 2018, Hebei General Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at Jining No.1 People's Hospital!
On Jul 5, 2018, Jining No.1 People's Hospital held DIRECT-MT initiation meeting.
DIRECT-MT was initiated at Nanyang City Center Hospital!
On Jul 11, 2018, DIRECT-MT initiation meeting was held at Nanyang City Center Hospital.
DIRECT-MT was initiated at Henan Provincial People's Hospital!
On Jul 11, 2018, DIRECT-MT initiation meeting was held at Henan Provincial People's Hospital.
DIRECT-MT was initiated at The First Affiliated Hospital of Zhengzhou University!
On Jul 12, 2018, DIRECT-MT initiation meeting was held at The First Affiliated Hospital of Zhengzhou University.
DIRECT-MT was initiated at Jiangsu Province Hospital!
On Jul 18, 2018, DIRECT-MT initiation meeting was held at Jiangsu Province Hospital.
DIRECT-MT was initiated at Tongji Hospital!
On Jul 24, 2018, DIRECT-MT initiation meeting was held at Tongji Hospital, Tongji University.
DIRECT-MT was initiated at The First Bethune Hospital of Jilin University!
On Oct 11, 2018, DIRECT-MT initiation meeting was held at The First Bethune Hospital of Jilin University.
DIRECT-MT was initiated at The First Affiliated Hospital of Harbin Medical University!
On Nov 15, 2018, DIRECT-MT initiation meeting was held at The First Affiliated Hospital of Harbin Medical University.
DIRECT-MT was initiated at The First Affiliated Hospital of Harbin Medical University!
Shengjing Hospital of China Medical University initiated DIRECT-MT on Dec 20, 2018!
On Dec 20, 2018, DIRECT-MT initiation meeting was held at Shengjing Hospital of China Medical University.
DSMB Meeting
The DSMB Meeting was held in Shanghai.
On May 31, 2018, we held the first DSMB Meeting in Shanghai. Prof. Craig Anderson (George Institute for Global Health) from Australia, the chairman of DSMB, discussed with another two experts of DSMB, Prof. Miao Zhongrong (Beijing Tian Tan Hospital) and Prof. He Jia (Department of Health Statistics of the Second Military Medical University), gave valuable recommendations for this study and elaborated a data and safety monitoring plan.
The DSMB Meeting is expected to be held once every six months.
The 2 nd DSMB Meeting was successfully held in Shanghai
On Oct 25, the 2nd DSMB Meeting was held in Shanghai. Prof. Anderson sent congratulations to DIRECT-MT that patient enrollment
were successfully and rapidly performed.
The 3 rd DSMB Meeting was successfully held in Shanghai
On Jun 22, 2019, the 3rd DSMB Meeting was held at Crowne Plaza Shanghai Fudan. Blinded data of 390 cases were analyzed and reported. SAE reports were concluded and displayed to the members. Problems including logistic statistics were discussed and solved. Meanwhile, the protocol of planned ENCHANTED-2 trial was also consulted prior to this meeting. The DSMB members declared that DIRECT-MT investigators should move on and achieve further conclusions.
Steering Committee Meeting
The Steering Committee meeting was held.
On Jun 17, 2018, the Steering Committee meeting held its first seminar.
The Steering Committee meeting was held.
On Jul 16, 2018, the Steering Committee meeting was held.
The Steering Committee meeting was held.
On Aug 21, 2018, the Steering Committee meeting was held.
The 5th Steering Committee Meeting was successfully held in Shanghai
On Oct 25, the 5th Steering Committee Meeting was successfully held in Shanghai. Prof. Jianmin Liu, Prof. Benqiang Deng,
Prof. Majoie and Prof. Roos and other PIs discussed the current problems and proposed solutions with pertinency.
1DIRECT-MT Steering CommitteeMeeting was held at Changhai Hospital.
On Dec10, 2018, the 6thDIRECT-MT Steering Committee Meeting was held at Changhai Hospital, Naval Medical University.
Monthly report was discussed and problems further settled.
1DIRECT-MT Steering CommitteeMeeting was held at Changhai Hospital.
On Feb09, 2019, the 7thDIRECT-MT Steering CommitteeMeeting was held at Changhai Hospital, Naval Medical University.
Monthly report was discussed. Interim report was also prepared.
The 8nd Executive Committee Meeting was held in Shanghai.
On Feb 20, 2019, the 8nd Executive Committee Meeting was successfully held in Shanghai.
The 9nd Executive Committee Meeting was held in Shanghai.
On April 3, 2019, the 9nd Executive Committee Meeting was successfully held in Shanghai. A huge progress was achieved in March, 2019, since the medium meeting was held.
The 11th Executive Committee Meeting was held in Shanghai.
On Jun 19, 2019, the 11th Executive Committee Meeting was successfully held in Shanghai. Preparation measures were simultaneously discussed at this meeting.
The 10th Executive Committee Meeting was held in Shanghai.
On May 15, 2019, the 10th Executive Committee Meeting was successfully held in Shanghai. Till now, 41 hospitals were participated. 573 cases were enrolled till May 4, 2019. The third data cleaning was completed in 99 cases and second data cleaning competed in 50 cases.
The 12th Executive Committee Meeting was held in Shanghai.
On Jul 18, 2019, the 12th Executive Committee Meeting was successfully held in Shanghai. All patients were enrolled till Jul 2, 2019 and the system was concurrently shut down. As planned, all statistical report would be completed at the end of October.
The 13th Executive Committee Meeting was held in Shanghai.
On Aug 9, 2019, the 13th Executive Committee Meeting was successfully held in Shanghai. All the imaging data was completed at the end of July. The plan was minorly adjusted on this meeting. Details of the advisory board meeting held in December was discussed.
The 14th Executive Committee Meeting was held in Shanghai.
On Sep 20, 2019, the 14th Executive Committee Meeting was successfully held in Shanghai. Till Sep 18, 2019, all centers’ follow-up were completed. The 8th data cleaning was performed during Aug 21 to Sep 10.
Clinical Events Committee Meeting
The 1st Clinical Events Committee Meeting was successfully held in Shanghai
On Oct 25, The 1st Clinical Events Committee Meeting was successfully held in Shanghai. Prof. Qi Fang, Prof. Majoie, Prof.
Roos and other members discussed the assessment protocols, definition of clinical events, unfavorable clinical outcomes etc.
Outcome Committee Meeting
The 1st Outcome Committee Meeting was successfully held in Shanghai
On Oct 25, The 1st Outcome Committee Meeting was successfully held in Shanghai. Prof. Yansheng Li, Prof. Majoie, Prof. Roos
and other members participated this Meeting and discussed the feasibility, impartiality and accuracy of outcome assessment
protocols.
Core Lab Meeting
The 1st Core Lab Meeting was held in Shanghai
On Oct 27, The 1st Core Lab Meeting was successfully held in Shanghai. Prof. Jianping Lu and other nine physicians and radiologists
consisted of the core lab that was in responsible for imaging assessment. They discussed the protocols of assessment and
trained for homogeneity.
Executive Committee Meeting
The 1st Executive Committee Meeting was successfully held in Shanghai
On Oct 26, The 1st Outcome Committee Meeting was successfully held in Shanghai. Prof. Benqiang Deng moderated this Meeting.
Prof. Pengfei Yang declared the most recent progress. Advanced units were rewarded with model prizes.
The 2nd Executive Committee Meeting was held in Shanghai.
On Feb.24th, 2019, the 2nd Executive Committee Meeting was successfully held in Shanghai. Trial quality, experience sharing and issues were discussed. Writing protocol was declared and discussed by all PI and participants. Medium result of DIRECT-MT trial was also discussed at the same day.
Advisory Board Meeting
The 1st Advisory Board Meeting was successfully held in Shanghai
Direct-MT 1st Advisory Board Meeting was held in Shanghai, Prof. Jianmin Liu and Prof. Pengfei Yang gave a brief introduction
of the general progress of Direct-MT, all the team members of Direct-MT and MR-CLEAN had a warm and friendly discussion.
Prof. Charles Mjoie, Prof. Yvo Roos and Prof. Diederik Dippel from MR-CLEAN Registry clinical trial provided advises about
the data quality control, progress management and shared experiences in the MR-CLEAN study.
Others
The study protocol and screening of sites were discussed for the DIRECT-MT study!
Nov, 07, 2017
With the strong support from nearly 50 sites across the country, the study protocol and screening of sites were discussed for the DIRECT-MT study. Problems were also discussed and handled.
The first version of the DIRECT-MT study protocol was formulated！
Dec, 01, 2017
In November 2017, the first version of the DIRECT-MT study protocol was formulated after many negotiations with the MR CLEAN team. Major changes to the protocol are as follows:
Oral ethical approval were obtained！
Jan, 04, 2018
On January 3, 2018, the project team completed the defense for ethical review by the leading site and obtained oral ethical approval. It is planned to obtain the EC approval letter within two weeks.
The sites participating in the study was re-reviewed!
Jan, 04, 2018
In order to ensure the high quality of study, the project team plans to re-review the sites participating in the study before the sub-sites submit the ethical reports. The criteria for re-review are as follows:
1. Does the site's clinical routine comply with the protocol requirements? The important thing is to determine whether an all-day CTA is conducted, whether the time to randomize patients to receive femoral artery puncture can be controlled within 60 minutes, and whether thrombolysis can commence after CTA.
2. Does the number of patient visits to the site keep consistent with the progress of enrollment? We hope to enroll 10 subjects in each site each year.
3. Does the site have any ongoing competitive study project or other factors that affect the implementation of the study?
The project team will commission CRO to contact each site participating in the study. Please coordinate if you receive a call from CRA. If your site is temporarily unable to meet the criteria for re-review, but may meet these criteria after a period of time, please inform CRA.
Ethical submissions of 13 participating centers were fulfilled.
Feb 13, 2018
Before the Spring Festival, ethical submissions of 13 centers were fulfilled, 3 of which have succeeded in the ethical review or the acceptance of ethical advice and have accessed the stage of agreement negotiating and signing. It is estimated that the project will be started at five centers after the Spring Festival.
The DIRECT-MT Promotion Meeting was held in Sweden!
On May 17, 2018, Prof. Yang Pengfei presented the design and progress of the DIRECT-MT study on behalf of the DIRECT-MT team
at the European Stroke Organization Conference (ESOC) in Gothenburg, Sweden. Participants are very much looking forward
to our progress and results.
On May 23, 2018, Prof. Yang Pengfei, on behalf of the DIRECT-MT team, attended the annual Investigators' Conference of MR
CLEAN team in Amsterdam, introduced detailed study progress to the MR CLEAN team, and made a deep discussion with the MR
CLEAN team about the current problems in detail and how to further improve the study quality. The MR CLEAN team spoke highly
of our study speed and case quality! We are looking forward to enabling efficient high-quality completion of the DIRECT-MT
study and the first delivery of voice of China in the international community!
14 sites were to initiate in April 2018!
Nov, 07, 2017
The study is estimated to be initiated in 14 sites in April 2018. At present, 44 sites across the country participate in the DIRECT-MT study.
|
|
|
|
|
|