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

February 4, 2024 updated by: Inje University Haeundae Paik Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 14647
        • The Catholic University of Korea, Bucheon St. Mary's Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of, 42406
        • Daegu Goodmorning Hospital
      • Daejeon, Korea, Republic of, 34134
        • Chungnam National University Hospital.
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Pohang, Korea, Republic of, 37659
        • Pohang S hospital
      • Pohang, Korea, Republic of, 37816
        • Pohang SM christianity Hospital
      • Suwon, Korea, Republic of, 16247
        • The Catholic University of Korea ST. Vincent's Hospital.
      • Uijeongbu, Korea, Republic of, 11765
        • The Catholic University of Korea Uijeongbu St. Mary's Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 10380
        • Inje University Ilsan Paik Hospital
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13497
        • Bundang CHA Hospital
    • Gyeongsangnam-do
      • Changwon, Gyeongsangnam-do, Korea, Republic of, 51353
        • Samsung Medical Center Sungkyunkwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: suction aspiration group
suction aspiration group is based on a large bore catheter for thrombus removal under negative pressure of pump or manual syringe.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological outcome using modified TICI grade (mTICI)
Time Frame: time of control angiography after retrieval of thrombectomy devices
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)
Time Frame: 3 months after thrombectomy
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)
Time Frame: time of control angiography after retrieval of thrombectomy devices
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)
Time Frame: 3 months after thrombectomy
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)
Time Frame: time of control angiography after retrieval of thrombectomy devices
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)
Time Frame: 3 months after thrombectomy
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)
Time Frame: time of control angiography after retrieval of thrombectomy devices
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)
Time Frame: 3 months after thrombectomy
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)
Time Frame: 3 months after thrombectomy
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
Time Frame: time of control angiography after retrieval of thrombectomy devices
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)
Time Frame: time of control angiography after retrieval of thrombectomy devices
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)
Time Frame: 3 months after thrombectomy
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 Frame: time interval from ER arrival time to femoral puncture
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)
Time Frame: time of control angiography after retrieval of thrombectomy devices
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)
Time Frame: 3 months after thrombectomy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
switching rate
Time Frame: time of switching from combination technique to suction aspiration
switching rate from combination technique to suction aspiration technique
time of switching from combination technique to suction aspiration
switching rate
Time Frame: time of switching from suction aspiration to combination technique
switching rate from suction aspiration technique to combination technique
time of switching from suction aspiration to combination technique
recanalization failure rate
Time Frame: time of final control angiogram immediately after thrombectomy
recanalization failure rate of IAT
time of final control angiogram immediately after thrombectomy
procedure related complication
Time Frame: admission period
procedural morbidity and mortality rate
admission period
non-procedural morbidity and mortality rate
Time Frame: admission period
non-procedure related events and death such as myocardial infarction, pneumonia, or sepsis
admission period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University Haeundae Paik Hospital

Collaborators

Korean Neuroendovascular Society

Investigators

  • Principal Investigator: Sung-Chul Jin, PhD, Department of Neurosurgery, Inje University, Haeundae Paik Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 4, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HaeundaePaikH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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