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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2027-01-30

Brief Summary

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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.

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Detailed Description

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\*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.

Conditions

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Acute Cerebral Ischemia Requiring for Mechanical Thrombectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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suction aspiration group

suction aspiration group is based on a large bore catheter for thrombus removal under negative pressure of pump or manual syringe.

Group Type EXPERIMENTAL

mechanical thrombectomy

Intervention Type 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

combination group is based on a stent retrieval with a large bore catheter for thrombus removal under negative pressure of pump or manual syringe.

Group Type ACTIVE_COMPARATOR

mechanical thrombectomy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No