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Clinical Trials in South Korea / NCT06254755
Enrolling by invitation Not applicable

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

NCT06254755 · tracked via the Priya Life Science South Korea tracker
Sponsor
Inje University Haeundae Paik Hospital
Phase
Not applicable
Started
2022-10-01
Last updated
2024-02-12

Condition(s) studied

Acute Cerebral Ischemia Requiring for Mechanical Thrombectomy

Investigational drug(s) / intervention(s)

mechanical thrombectomy

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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 outcome measure(s)

  • Radiological outcome using modified TICI grade (mTICI) — 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.
  • clinical outcome using modified Rankin Scale(mRS) — 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.
  • Radiological outcome caused by cardioembolism using using modified TICI grade (mTICI) — 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.
  • clinical outcome cause by cardioembolism using modified Rankin Scale(mRS) — 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.
  • radiological outcome in M1 occlusion using modified TICI grade (mTICI) — 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.
  • clinical outcome in M1 occlusion using modified Rankin Scale(mRS) — 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.
  • radiological outcome in M2 occlusion using modified TICI grade (mTICI) — 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.
  • clinical outcome in M2 occlusion using modified Rankin Scale(mRS) — 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.
  • 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) — 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.
  • 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 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.
  • 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 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.
  • 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) — 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.
  • comparison of door-to-puncture time between hot-line prehospital tele-communication and conventional group — time interval from ER arrival time to femoral puncture
    time interval between emergent room arrival time and femoral puncture
  • comparison of radiological outcome between hot-line prehospital tele-communication and conventional group using modified TICI grade (mTICI) — 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.
  • comparison of clinical outcome 3 months after IAT between hot-line prehospital tele-communication and conventional group using modified Rankin Scale(mRS) — 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.

Trial sites (13)

FacilityCityRegionStatus
Inje University Ilsan Paik Hospital Goyang-si Gyeonggi-do
Bundang Cha Hospital Seongnam-si Gyeonggi-do
Samsung Medical Center Sungkyunkwan University Changwon Gyeongsangnam-do
The Catholic University of Korea, Bucheon ST. Mary's Hospital Bucheon-si South Korea
Daegu Goodmorning Hospital Daegu South Korea
Yeungnam University Medical Center Daegu South Korea
Chungnam National University Hospital. Daejeon South Korea
Inha University Hospital Incheon South Korea
Pohang S hospital Pohang South Korea
Pohang SM christianity Hospital Pohang South Korea
The Catholic University of Korea ST. Vincent's Hospital. Suwon South Korea
The Catholic University of Korea Uijeongbu St. Mary's Hospital Uijeongbu-si South Korea
Ulsan university Hospital Ulsan South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06254755 on ClinicalTrials.gov ↗ ← All trials in South Korea