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| Name | Class |
|---|---|
| Korean Neuroendovascular Society | UNKNOWN |
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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.
*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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suction aspiration group | Experimental | suction aspiration group is based on a large bore catheter for thrombus removal under negative pressure of pump or manual syringe. |
|
| combination group | Active Comparator | combination group is based on a stent retrieval with a large bore catheter for thrombus removal under negative pressure of pump or manual syringe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mechanical thrombectomy | Device | mechanical thrombectomy of acute ischemic stroke caused by major vessel occlusion of the anterior circulation has become an accepted procedure in the last decade. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological outcome using modified TICI grade (mTICI) | 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. | time of control angiography after retrieval of thrombectomy devices |
| clinical outcome using modified Rankin Scale(mRS) | 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. | 3 months after thrombectomy |
| Radiological outcome caused by cardioembolism using using modified TICI grade (mTICI) | 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. | time of control angiography after retrieval of thrombectomy devices |
| clinical outcome cause by cardioembolism using modified Rankin Scale(mRS) | 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. | 3 months after thrombectomy |
| radiological outcome in M1 occlusion using modified TICI grade (mTICI) | 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. | time of control angiography after retrieval of thrombectomy devices |
| clinical outcome in M1 occlusion using modified Rankin Scale(mRS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| switching rate | switching rate from combination technique to suction aspiration technique | time of switching from combination technique to suction aspiration |
| switching rate | switching rate from suction aspiration technique to combination technique |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Chul Jin, PhD | Department of Neurosurgery, Inje University, Haeundae Paik Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do | 10380 | South Korea | ||
| Bundang Cha Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29038080 | Background | Goto S, Ohshima T, Ishikawa K, Yamamoto T, Shimato S, Nishizawa T, Kato K. A Stent-Retrieving into an Aspiration Catheter with Proximal Balloon (ASAP) Technique: A Technique of Mechanical Thrombectomy. World Neurosurg. 2018 Jan;109:e468-e475. doi: 10.1016/j.wneu.2017.10.004. Epub 2017 Oct 13. | |
| 26908591 | Background |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
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Non-inferiority, open-labelled, randomization, case-controlled prospective multicenter trials
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| 3 months after thrombectomy |
| radiological outcome in M2 occlusion using modified TICI grade (mTICI) | 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. | time of control angiography after retrieval of thrombectomy devices |
| clinical outcome in M2 occlusion using modified Rankin Scale(mRS) | 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. | 3 months after thrombectomy |
| 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) | 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. | 3 months after thrombectomy |
| 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 | 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. | time of control angiography after retrieval of thrombectomy devices |
| comparison of radiological outcome between rescue treatment of primary stenting and sequential treatment in large artery atherosclerotic steno-occlusion using modified TICI grade (mTICI) | 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. | time of control angiography after retrieval of thrombectomy devices |
| 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) | 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. | 3 months after thrombectomy |
| comparison of door-to-puncture time between hot-line prehospital tele-communication and conventional group | time interval between emergent room arrival time and femoral puncture | time interval from ER arrival time to femoral puncture |
| comparison of radiological outcome between hot-line prehospital tele-communication and conventional group using modified TICI grade (mTICI) | 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. | time of control angiography after retrieval of thrombectomy devices |
| comparison of clinical outcome 3 months after IAT between hot-line prehospital tele-communication and conventional group using modified Rankin Scale(mRS) | 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. | 3 months after thrombectomy |
| time of switching from suction aspiration to combination technique |
| recanalization failure rate | recanalization failure rate of IAT | time of final control angiogram immediately after thrombectomy |
| procedure related complication | procedural morbidity and mortality rate | admission period |
| non-procedural morbidity and mortality rate | non-procedure related events and death such as myocardial infarction, pneumonia, or sepsis | admission period |
| Seongnam-si |
| Gyeonggi-do |
| 13497 |
| South Korea |
| Samsung Medical Center Sungkyunkwan University | Changwon | Gyeongsangnam-do | 51353 | South Korea |
| The Catholic University of Korea, Bucheon ST. Mary's Hospital | Bucheon-si | 14647 | South Korea |
| Daegu Goodmorning Hospital | Daegu | 42406 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Chungnam National University Hospital. | Daejeon | 34134 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Pohang S hospital | Pohang | 37659 | South Korea |
| Pohang SM christianity Hospital | Pohang | 37816 | South Korea |
| The Catholic University of Korea ST. Vincent's Hospital. | Suwon | 16247 | South Korea |
| The Catholic University of Korea Uijeongbu St. Mary's Hospital | Uijeongbu-si | 11765 | South Korea |
| Ulsan university Hospital | Ulsan | 44033 | South Korea |
| Massari F, Henninger N, Lozano JD, Patel A, Kuhn AL, Howk M, Perras M, Brooks C, Gounis MJ, Kan P, Wakhloo AK, Puri AS. ARTS (Aspiration-Retriever Technique for Stroke): Initial clinical experience. Interv Neuroradiol. 2016 Jun;22(3):325-32. doi: 10.1177/1591019916632369. Epub 2016 Feb 22. |
| 29222393 | Background | Maegerlein C, Monch S, Boeckh-Behrens T, Lehm M, Hedderich DM, Berndt MT, Wunderlich S, Zimmer C, Kaesmacher J, Friedrich B. PROTECT: PRoximal balloon Occlusion TogEther with direCt Thrombus aspiration during stent retriever thrombectomy - evaluation of a double embolic protection approach in endovascular stroke treatment. J Neurointerv Surg. 2018 Aug;10(8):751-755. doi: 10.1136/neurintsurg-2017-013558. Epub 2017 Dec 8. |
| 28691137 | Background | Lee DH, Sung JH, Kim SU, Yi HJ, Hong JT, Lee SW. Effective use of balloon guide catheters in reducing incidence of mechanical thrombectomy related distal embolization. Acta Neurochir (Wien). 2017 Sep;159(9):1671-1677. doi: 10.1007/s00701-017-3256-3. Epub 2017 Jul 9. |
| 28754806 | Background | Brinjikji W, Starke RM, Murad MH, Fiorella D, Pereira VM, Goyal M, Kallmes DF. Impact of balloon guide catheter on technical and clinical outcomes: a systematic review and meta-analysis. J Neurointerv Surg. 2018 Apr;10(4):335-339. doi: 10.1136/neurintsurg-2017-013179. Epub 2017 Jul 28. |
| 28702117 | Background | Karanam LSP, Sharma M, Alurkar A, Baddam SR, Pamidimukkala V, Polavarapu R. Balloon Angioplasty for Intracranial Atherosclerotic Disease: A Multicenter Study. J Vasc Interv Neurol. 2017 Jun;9(4):29-34. |
| 30413831 | Result | Maegerlein C, Berndt MT, Monch S, Kreiser K, Boeckh-Behrens T, Lehm M, Wunderlich S, Zimmer C, Friedrich B. Further Development of Combined Techniques Using Stent Retrievers, Aspiration Catheters and BGC : The PROTECTPLUS Technique. Clin Neuroradiol. 2020 Mar;30(1):59-65. doi: 10.1007/s00062-018-0742-9. Epub 2018 Nov 9. |
| 29628942 | Result | Malisch TW, Zaidat OO, Castonguay AC, Marden FA, Gupta R, Sun CJ, Martin CO, Holloway WE, Mueller-Kronast N, English J, Linfante I, Dabus G, Bozorgchami H, Xavier A, Rai AT, Froehler M, Badruddin A, Nguyen TN, Taqi MA, Abraham MG, Janardhan V, Shaltoni H, Novakovic R, Yoo AJ, Abou-Chebl A, Chen PR, Britz GW, Kaushal R, Nanda A, Nogueira RG. Clinical and Angiographic Outcomes with the Combined Local Aspiration and Retriever in the North American Solitaire Stent-Retriever Acute Stroke (NASA) Registry. Interv Neurol. 2018 Feb;7(1-2):26-35. doi: 10.1159/000480353. Epub 2017 Oct 11. |
| 28271328 | Result | Maegerlein C, Prothmann S, Lucia KE, Zimmer C, Friedrich B, Kaesmacher J. Intraprocedural Thrombus Fragmentation During Interventional Stroke Treatment: A Comparison of Direct Thrombus Aspiration and Stent Retriever Thrombectomy. Cardiovasc Intervent Radiol. 2017 Jul;40(7):987-993. doi: 10.1007/s00270-017-1614-4. Epub 2017 Mar 7. |
| 34581737 | Result | Lapergue B, Blanc R, Costalat V, Desal H, Saleme S, Spelle L, Marnat G, Shotar E, Eugene F, Mazighi M, Houdart E, Consoli A, Rodesch G, Bourcier R, Bracard S, Duhamel A, Ben Maacha M, Lopez D, Renaud N, Labreuche J, Gory B, Piotin M; ASTER2 Trial Investigators. Effect of Thrombectomy With Combined Contact Aspiration and Stent Retriever vs Stent Retriever Alone on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER2 Randomized Clinical Trial. JAMA. 2021 Sep 28;326(12):1158-1169. doi: 10.1001/jama.2021.13827. |
| 26667250 | Result | Delgado Almandoz JE, Kayan Y, Young ML, Fease JL, Scholz JM, Milner AM, Hehr TH, Roohani P, Mulder M, Tarrel RM. Comparison of clinical outcomes in patients with acute ischemic strokes treated with mechanical thrombectomy using either Solumbra or ADAPT techniques. J Neurointerv Surg. 2016 Nov;8(11):1123-1128. doi: 10.1136/neurintsurg-2015-012122. Epub 2015 Dec 14. |
| 32327379 | Result | Kim SH, Lee H, Kim SB, Kim ST, Baek JW, Heo YJ, Jeong HW, Kim HJ, Park JH, Kim JS, Jin SC. Hybrid mechanical thrombectomy for acute ischemic stroke using an intermediate aspiration catheter and Trevo stent simultaneously. J Clin Neurosci. 2020 Jun;76:9-14. doi: 10.1016/j.jocn.2020.04.079. Epub 2020 Apr 21. |
| 42011003 | Derived | Lee J, Sheen SH, Jin SC, Choi Y, Hyun D, Shim YS, Kim T, Bae J, Kim CH, Kwon MY, Choi YJ, Hong D, Kim Y, Jeong EO, Kwon HJ, Lee Y, Lee J, Ryu S, Goh DH, Kim SY, Kwon SC, Lee JM, Koo HW, Jung Y, Kim J, Chang CH, Oh JS, Kim YW, Baek J, Kim KW; COMPETE Trials Investigators. Comparison of Clinical and Radiological Outcomes Between Suction Aspiration and Combination Methods of Mechanical Thrombectomy in Patients With Acute Cerebral Infarction: The COMPETE Trial. J Korean Med Sci. 2026 Apr 20;41(15):e164. doi: 10.3346/jkms.2026.41.e164. |