Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06254755
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-12
First Post:
2024-01-17
Brief Title:
Comparison Study Between Suction Aspiration and Combination Technique in Acute Cerebral Infarction
Sponsor:
Inje University Haeundae Paik Hospital
Organization:
Inje University Haeundae Paik Hospital
Study Overview
Official Title:
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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:
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 aspirationstent 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
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
Detailed Description:
Hospital code for the participant hospitals Bundang Cha Hospital A Inje University Haeundae Paik HospitalI Samsung Medical Center Sungkyunkwan University B Kosin University Gospel Hospital C Daegu Good morning Hospital D Yeungnam University Medical Center E Pohang S hospitalG Inje University Ilsan Paik HospitalH SM christianity Pohang HospitalL Choongnam National University HospitalN Inha University HospitalP Catholic University of Korea Bucheon ST Marys Hospital Q Catholic University of Korea Uijeongbu ST Marys Hospital R Catholic University of Korea ST Vincents 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
This study should not enroll atherosclerotic tandem occlusion Other etiologies such as cancer related stroke or dissection should not be enrolled in this study
Cases of Atherosclerotic steno-occlusion will be included in this study Rescue treatment such as primary stenting or conventional modality will be performed according to the favored modality of each investigator
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
This study should not enroll atherosclerotic tandem occlusion Other etiologies such as cancer related stroke or dissection should not be enrolled in this study
Cases of Atherosclerotic steno-occlusion will be included in this study Rescue treatment such as primary stenting or conventional modality will be performed according to the favored modality of each investigator
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