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

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

Overview

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.

Detailed description

\*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.

Interventions

• Device mechanical thrombectomy
  mechanical thrombectomy of acute ischemic stroke caused by major vessel occlusion of the anterior circulation has become an accepted procedure in the last decade.

Primary outcome measures

• Radiological outcome using modified TICI grade (mTICI) [Time frame: time of control angiography after retrieval of thrombectomy devices]
• clinical outcome using modified Rankin Scale(mRS) [Time frame: 3 months after thrombectomy]
• Radiological outcome caused by cardioembolism using using modified TICI grade (mTICI) [Time frame: time of control angiography after retrieval of thrombectomy devices]
• clinical outcome cause by cardioembolism using modified Rankin Scale(mRS) [Time frame: 3 months after thrombectomy]
• radiological outcome in M1 occlusion using modified TICI grade (mTICI) [Time frame: time of control angiography after retrieval of thrombectomy devices]
• clinical outcome in M1 occlusion using modified Rankin Scale(mRS) [Time frame: 3 months after thrombectomy]
• radiological outcome in M2 occlusion using modified TICI grade (mTICI) [Time frame: time of control angiography after retrieval of thrombectomy devices]
• clinical outcome in M2 occlusion using modified Rankin Scale(mRS) [Time frame: 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) [Time frame: 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 [Time frame: time of control angiography after retrieval of thrombectomy devices]

Secondary outcome measures (5)

• switching rate [Time frame: time of switching from combination technique to suction aspiration]
• switching rate [Time frame: time of switching from suction aspiration to combination technique]
• recanalization failure rate [Time frame: time of final control angiogram immediately after thrombectomy]
• procedure related complication [Time frame: admission period]
• non-procedural morbidity and mortality rate [Time frame: admission period]

Eligibility criteria

Inclusion criteria

• interventionist
• minimal experiences of thrombectomy ≥ 50 cases
• successful recanalization (TICI≥2b) of radiological outcome in all cases treated by thrombectomy > 70% Patient inclusion criteria
• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 13 centers

• Inje University Ilsan Paik Hospital — Goyang-si
• Bundang Cha Hospital — Seongnam-si
• Samsung Medical Center Sungkyunkwan University — Changwon
• The Catholic University of Korea, Bucheon ST. Mary's Hospital — Bucheon-si
• Daegu Goodmorning Hospital — Daegu
• Yeungnam University Medical Center — Daegu
• Chungnam National University Hospital. — Daejeon
• Inha University Hospital — Incheon
• … and 5 more centers

Publications

• 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
• 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
• 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-2017-0 PMID 29222393
• 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
• 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
• 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
• 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
• 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 Loca PMID 29628942

Identifiers

NCT: NCT06254755 · HaeundaePaikH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗