Comparison Study Between Suction Aspiration and Combination Technique in Acute Cerebral Infarction

NCT06254755 | Enrolling By Invitation

• 1 other identifier: HaeundaePaikH
• Study Type: interventional
• Target: 1,132
• Locations: 1 country
• Sites: 13

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 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.

Conditions

Acute Cerebral Ischemia Requiring for Mechanical Thrombectomy

Keywords

acute cerebral infarction, mechanical thrombectomy, suction aspiration, combination

Outcome Measures

Primary Outcomes (15)

• 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.

  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

Secondary Outcomes (5)

• switching rate

  time of switching from combination technique to suction aspiration

• switching rate

  time of switching from suction aspiration to combination technique

• recanalization failure rate

  time of final control angiogram immediately after thrombectomy

• procedure related complication

  admission period

• non-procedural morbidity and mortality rate

  admission period

Study Arms (2)

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.

Device: mechanical thrombectomy

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.

Device: mechanical thrombectomy

Interventions

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.

combination group; suction aspiration group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• interventionist
• minimal experiences of thrombectomy ≥ 50 cases
• age ≥ 18
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inje University Haeundae Paik Hospital: lead
• Korean Neuroendovascular Society: collaborator

Study Sites (13)

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

Bundang Cha Hospital

Seongnam-si, Gyeonggi-do, 13497, South Korea

Location

Samsung Medical Center Sungkyunkwan University

Changwon, Gyeongsangnam-do, 51353, South Korea

Location

The Catholic University of Korea, Bucheon ST. Mary's Hospital

Bucheon-si, 14647, South Korea

Location

Daegu Goodmorning Hospital

Daegu, 42406, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Chungnam National University Hospital.

Daejeon, 34134, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Pohang S hospital

Pohang, 37659, South Korea

Location

Pohang SM christianity Hospital

Pohang, 37816, South Korea

Location

The Catholic University of Korea ST. Vincent's Hospital.

Suwon, 16247, South Korea

Location

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, 11765, South Korea

Location

Ulsan university Hospital

Ulsan, 44033, South Korea

Location

Related Publications (12)

• 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.

  PMID: 29038080 BACKGROUND

• 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.

  PMID: 26908591 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.

  PMID: 29222393 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.

  PMID: 28691137 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.

  PMID: 28754806 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.

  PMID: 28702117 BACKGROUND

• 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.

  PMID: 30413831 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.

  PMID: 29628942 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.

  PMID: 28271328 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.

  PMID: 34581737 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.

  PMID: 26667250 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.

  PMID: 32327379 RESULT

Study Officials

• Sung-Chul Jin, PhD

  Department of Neurosurgery, Inje University, Haeundae Paik Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-inferiority, open-labelled, randomization, case-controlled prospective multicenter trials

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 12, 2024
• Study Start: October 1, 2022
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (13)