Clinical trial NCT06254755: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Acute Cerebral Ischemia Requiring for Mechanical Thrombectomy
Keywords: acute cerebral infarction, mechanical thrombectomy, suction aspiration, combination
Lead sponsor: Inje University Haeundae Paik Hospital
Sponsor class: OTHER
Collaborators: name: Korean Neuroendovascular Society
First posted: 2024-02-12
Enrollment: 1132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority, open-labelled, randomization, case-controlled prospective multicenter trials
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Radiological outcome using modified TICI grade (mTICI)
timeFrame: time of control angiography after retrieval of thrombectomy devices
measure: clinical outcome using modified Rankin Scale(mRS)
timeFrame: 3 months after thrombectomy
measure: Radiological outcome caused by cardioembolism using using modified TICI grade (mTICI)
timeFrame: time of control angiography after retrieval of thrombectomy devices
measure: clinical outcome cause by cardioembolism using modified Rankin Scale(mRS)
timeFrame: 3 months after thrombectomy
measure: radiological outcome in M1 occlusion using modified TICI grade (mTICI)
timeFrame: time of control angiography after retrieval of thrombectomy devices
measure: clinical outcome in M1 occlusion using modified Rankin Scale(mRS)
timeFrame: 3 months after thrombectomy
measure: radiological outcome in M2 occlusion using modified TICI grade (mTICI)
timeFrame: time of control angiography after retrieval of thrombectomy devices
measure: clinical outcome in M2 occlusion using modified Rankin Scale(mRS)
timeFrame: 3 months after thrombectomy
measure: 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)
timeFrame: 3 months after thrombectomy
measure: 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
timeFrame: time of control angiography after retrieval of thrombectomy devices
measure: comparison of radiological outcome between rescue treatment of primary stenting and sequential treatment in large artery atherosclerotic steno-occlusion using modified TICI grade (mTICI)
timeFrame: time of control angiography after retrieval of thrombectomy devices
measure: 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)
timeFrame: 3 months after thrombectomy
measure: comparison of door-to-puncture time between hot-line prehospital tele-communication and conventional group
timeFrame: time interval from ER arrival time to femoral puncture
measure: comparison of radiological outcome between hot-line prehospital tele-communication and conventional group using modified TICI grade (mTICI)
timeFrame: time of control angiography after retrieval of thrombectomy devices
measure: comparison of clinical outcome 3 months after IAT between hot-line prehospital tele-communication and conventional group using modified Rankin Scale(mRS)
timeFrame: 3 months after thrombectomy
Secondary outcomes:
measure: switching rate
timeFrame: time of switching from combination technique to suction aspiration
measure: switching rate
timeFrame: time of switching from suction aspiration to combination technique
measure: recanalization failure rate
timeFrame: time of final control angiogram immediately after thrombectomy
measure: procedure related complication
timeFrame: admission period
measure: non-procedural morbidity and mortality rate
timeFrame: admission period
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Bundang Cha Hospital
state: Gyeonggi-do
city: Changwon
country: Korea, Republic of
facility: Samsung Medical Center Sungkyunkwan University
state: Gyeongsangnam-do
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon ST. Mary's Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Goodmorning Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital.
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Pohang
country: Korea, Republic of
facility: Pohang S hospital
city: Pohang
country: Korea, Republic of
facility: Pohang SM christianity Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea ST. Vincent's Hospital.
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan university Hospital
Study officials:
affiliation: Department of Neurosurgery, Inje University, Haeundae Paik Hospital
name: Sung-Chul Jin, PhD
role: PRINCIPAL_INVESTIGATOR
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