Comparison of Clinical and Radiological Outcomes Between Suction Aspiration Method and Combination Method of Intra-arterial Therapy (IAT) in Large Artery Occlusion: Randomized Open-labelled Prospective Multicenter Trials
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,132
- 试验地点
- 26
- 主要终点
- Radiological outcome using modified TICI grade (mTICI)
研究概览
简要总结
Mechanical thrombectomy of acute ischemic stroke caused by major vessel occlusion of the anterior circulation has become an accepted procedure in the last decade. Recent IAT modalities have been classified as suction aspiration,stent retrieval and combination modality. The suction aspiration technique is limited by the possibility of breaking the entire thrombus during the IAT. In addition, the stent retrieval technique is also limited because of thrombus migration during stent removal from an acute-angled artery as in the case of a carotid siphon.
According to recent development of suction catheter, investigators expected that suction aspiration will prevent breaking the entire thrombus during the IAT. Investigators will evaluate the radiological and clinical outcome of suction aspiration technique in comparison with combination technique in the large artery occlusion feasible to both suction aspiration and combination technique prospectively in a randomized trial.
详细描述
*Hospital code for the participant hospitals Bundang Cha Hospital (A) Inje University Haeundae Paik Hospital(I) Samsung Medical Center Sungkyunkwan University (B) Kosin University Gospel Hospital (C) Daegu Good morning Hospital (D) Yeungnam University Medical Center (E) Pohang S hospital(G) Inje University Ilsan Paik Hospital(H) SM christianity Pohang Hospital(L) Choongnam National University Hospital(N) Inha University Hospital(P) Catholic University of Korea Bucheon ST. Mary's Hospital (Q) Catholic University of Korea Uijeongbu ST. Mary's Hospital (R) Catholic University of Korea ST. Vincent's Hospital (S) Ulsan University Hospital (U)
Alphabetic number of each hospital is an each hospital code.
If the patient with acute cerebral infarction will be feasible to suction aspiration and combination technique, the investigator who can enroll the patient should check the order of random table in open chatting board and perform the ordered method after completion of consent for the COMPETE trials.
Each investigator in the hospitals participated in COMPETE trials will write the competetrials spread sheet on google web.
The image files of thrombectomy including pre-thrombectomy and post-thrombectomy will be converted to zip file and send to the independent neurointerventional radiologist on e-mail about 2 ~ 4 times a year. the independent examiner will re-send to the investigator after completion of modified TICI grade in the image files of thrombectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •interventionist
- •minimal experiences of thrombectomy ≥ 50 cases
- •successful recanalization (TICI≥2b) of radiological outcome in all cases treated by thrombectomy > 70% Patient inclusion criteria
- •acute cerebral infarction with initial NIHSS ≥ 4
- •patients with agreement for clinical trials
- •detection of large artery occlusion based on CT or Magnetic resonance angiography
- •definition of large artery occlusion: 1) anterior circulation internal carotid artery(ICA), M1, M2 segment A1, A2 segment 2)posterior circulation Vertebrobasilar occlusion including P1 segment
- •Last normal time ≤ 24 hours
- •Flow/volume mismatch ≥ 1/2 based on perfusion image
排除标准
- •Previous disabled patients before mechanical thrombectomy(MT) (Karnofsky performance Status Scale(KPS) ≤ 80)
- •Patient or patient's guardian refused to the clinical trial
- •Small vessel disease of TOAST classification
- •Other determined etiologies of TOAST classification
- •Patients with Initial NIHSS ≤ 3
- •Diffusion/perfusion matched lesion or flow/volume matched lesion
结局指标
主要结局
Radiological outcome using modified TICI grade (mTICI)
时间窗: time of control angiography after retrieval of thrombectomy devices
modified TICI grade is composed of 0, 1, 2a,2b,2c, and 3. O of modified TICI grade is no recanalized state. 3 of modified TICI grade is completely recanalized state.
clinical outcome using modified Rankin Scale(mRS)
时间窗: 3 months after thrombectomy
modified Rankin scale is composed of 0,1,2,3,4,5, and. Oof mRS is no neurological deficit. 6 of mRS is mortality case.
clinical outcome cause by cardioembolism using modified Rankin Scale(mRS)
时间窗: 3 months after thrombectomy
modified Rankin scale is composed of 0,1,2,3,4,5, and. Oof mRS is no neurological deficit. 6 of mRS is mortality case.
clinical outcome in M1 occlusion using modified Rankin Scale(mRS)
时间窗: 3 months after thrombectomy
modified Rankin scale is composed of 0,1,2,3,4,5, and. Oof mRS is no neurological deficit. 6 of mRS is mortality case.
comparison of clinical outcome 3 months after IAT between mismatch more than 1/2 based on flow/volume of CT perfusion and calculated volume of mismatch using modified Rankin Scale(mRS)
时间窗: 3 months after thrombectomy
modified Rankin scale is composed of 0,1,2,3,4,5, and. Oof mRS is no neurological deficit. 6 of mRS is mortality case.
Radiological outcome caused by cardioembolism using using modified TICI grade (mTICI)
时间窗: time of control angiography after retrieval of thrombectomy devices
modified TICI grade is composed of 0, 1, 2a,2b,2c, and 3. O of modified TICI grade is no recanalized state. 3 of modified TICI grade is completely recanalized state.
clinical outcome in M2 occlusion using modified Rankin Scale(mRS)
时间窗: 3 months after thrombectomy
modified Rankin scale is composed of 0,1,2,3,4,5, and. Oof mRS is no neurological deficit. 6 of mRS is mortality case.
radiological outcome in M1 occlusion using modified TICI grade (mTICI)
时间窗: time of control angiography after retrieval of thrombectomy devices
modified TICI grade is composed of 0, 1, 2a,2b,2c, and 3. O of modified TICI grade is no recanalized state. 3 of modified TICI grade is completely recanalized state.
radiological outcome in M2 occlusion using modified TICI grade (mTICI)
时间窗: time of control angiography after retrieval of thrombectomy devices
modified TICI grade is composed of 0, 1, 2a,2b,2c, and 3. O of modified TICI grade is no recanalized state. 3 of modified TICI grade is completely recanalized state.
comparison of radiological outcome between more than 1/2 based on flow/volume of CT perfusion and calculated volume of mismatch based on flow/volume of CT perfusion
时间窗: time of control angiography after retrieval of thrombectomy devices
modified TICI grade is composed of 0, 1, 2a,2b,2c, and 3. O of modified TICI grade is no recanalized state. 3 of modified TICI grade is completely recanalized state.
comparison of clinical outcome 3 months after IAT between rescue treatment of primary stenting and sequential treatment in large artery atherosclerotic steno-occlusion using modified Rankin Scale(mRS)
时间窗: 3 months after thrombectomy
modified Rankin scale is composed of 0,1,2,3,4,5, and. Oof mRS is no neurological deficit. 6 of mRS is mortality case.
comparison of radiological outcome between hot-line prehospital tele-communication and conventional group using modified TICI grade (mTICI)
时间窗: time of control angiography after retrieval of thrombectomy devices
modified TICI grade is composed of 0, 1, 2a,2b,2c, and 3. O of modified TICI grade is no recanalized state. 3 of modified TICI grade is completely recanalized state.
comparison of clinical outcome 3 months after IAT between hot-line prehospital tele-communication and conventional group using modified Rankin Scale(mRS)
时间窗: 3 months after thrombectomy
modified Rankin scale is composed of 0,1,2,3,4,5, and. Oof mRS is no neurological deficit. 6 of mRS is mortality case.
comparison of radiological outcome between rescue treatment of primary stenting and sequential treatment in large artery atherosclerotic steno-occlusion using modified TICI grade (mTICI)
时间窗: time of control angiography after retrieval of thrombectomy devices
modified TICI grade is composed of 0, 1, 2a,2b,2c, and 3. O of modified TICI grade is no recanalized state. 3 of modified TICI grade is completely recanalized state.
comparison of door-to-puncture time between hot-line prehospital tele-communication and conventional group
时间窗: time interval from ER arrival time to femoral puncture
time interval between emergent room arrival time and femoral puncture
次要结局
- recanalization failure rate(time of final control angiogram immediately after thrombectomy)
- switching rate(time of switching from suction aspiration to combination technique)
- procedure related complication(admission period)
- non-procedural morbidity and mortality rate(admission period)