Acute Cerebral Ischemia Requiring for Mechanical ThrombectomyNCT06254755

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

A study testing mechanical thrombectomy in people with Acute Cerebral Ischemia Requiring for Mechanical Thrombectomy, run by Inje University Haeundae Paik Hospital at 13 sites in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Acute Cerebral Ischemia Requiring for Mechanical Thrombectomy
What is being tested?: mechanical thrombectomy
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,132 participants
Where: 13 sitesSouth Korea
Study dates: 1 Oct 2022to 30 Jan 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

City, postcode or hospital

13 sites in 1 country

South Korea13 sites

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

Other trials in South Korea

About this study

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

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.

Read the 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.

Conditions: Acute Cerebral Ischemia Requiring for Mechanical Thrombectomy
Being tested: mechanical thrombectomy
Keywords: acute cerebral infarction, mechanical thrombectomy, suction aspiration, combination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mechanical thrombectomyDevice
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 groups in NCT06254755
Study group	Role	What they receive
suction aspiration group	Experimental	suction aspiration group is based on a large bore catheter for thrombus removal under negative pressure of pump or manual syringe. Receives: Device: mechanical thrombectomy
combination group	Active comparator	combination group is based on a stent retrieval with a large bore catheter for thrombus removal under negative pressure of pump or manual syringe. Receives: Device: mechanical thrombectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiological outcome using modified TICI grade (mTICI)
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.
Measured: time of control angiography after retrieval of thrombectomy devices
clinical outcome using modified Rankin Scale(mRS)
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.
Measured: 3 months after thrombectomy
Radiological outcome caused by cardioembolism using using modified TICI grade (mTICI)
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.
Measured: time of control angiography after retrieval of thrombectomy devices
clinical outcome cause by cardioembolism using modified Rankin Scale(mRS)
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.
Measured: 3 months after thrombectomy
radiological outcome in M1 occlusion using modified TICI grade (mTICI)
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.
Measured: time of control angiography after retrieval of thrombectomy devices
clinical outcome in M1 occlusion using modified Rankin Scale(mRS)
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.
Measured: 3 months after thrombectomy
radiological outcome in M2 occlusion using modified TICI grade (mTICI)
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.
Measured: time of control angiography after retrieval of thrombectomy devices
clinical outcome in M2 occlusion using modified Rankin Scale(mRS)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 3 months after thrombectomy
comparison of door-to-puncture time between hot-line prehospital tele-communication and conventional group
time interval between emergent room arrival time and femoral puncture
Measured: 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)
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.
Measured: 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)
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.
Measured: 3 months after thrombectomy

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202230 Jan 2027

First posted12 Feb 2024
Study start1 Oct 2022
Primary completion30 Jan 2027 (estimated)
Study completion30 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Acute Cerebral Ischemia Requiring for Mechanical ThrombectomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Non-inferiority, open-labelled, randomization, case-controlled prospective multicenter trials
Masking: None (open label)
Enrolment: 1,132 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06254755
Sponsor's protocol ID: HaeundaePaikH
Status last verified: Feb 2024
First submitted: 17 Jan 2024
Last updated: 12 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 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.
PubMed 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-2017-013558. Epub 2017 Dec 8.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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 Local Aspiration and Retriever in the North American Solitaire Stent-Retriever Acute Stroke (NASA) Registry. Interv Neurol. 2018 Feb;7(1-2):26-35. doi: 10.1159/000480353. Epub 2017 Oct 11.
PubMed 29628942
Maegerlein C, Prothmann S, Lucia KE, Zimmer C, Friedrich B, Kaesmacher J. Intraprocedural Thrombus Fragmentation During Interventional Stroke Treatment: A Comparison of Direct Thrombus Aspiration and Stent Retriever Thrombectomy. Cardiovasc Intervent Radiol. 2017 Jul;40(7):987-993. doi: 10.1007/s00270-017-1614-4. Epub 2017 Mar 7.
PubMed 28271328
Lapergue B, Blanc R, Costalat V, Desal H, Saleme S, Spelle L, Marnat G, Shotar E, Eugene F, Mazighi M, Houdart E, Consoli A, Rodesch G, Bourcier R, Bracard S, Duhamel A, Ben Maacha M, Lopez D, Renaud N, Labreuche J, Gory B, Piotin M; ASTER2 Trial Investigators. Effect of Thrombectomy With Combined Contact Aspiration and Stent Retriever vs Stent Retriever Alone on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER2 Randomized Clinical Trial. JAMA. 2021 Sep 28;326(12):1158-1169. doi: 10.1001/jama.2021.13827.
PubMed 34581737
Delgado Almandoz JE, Kayan Y, Young ML, Fease JL, Scholz JM, Milner AM, Hehr TH, Roohani P, Mulder M, Tarrel RM. Comparison of clinical outcomes in patients with acute ischemic strokes treated with mechanical thrombectomy using either Solumbra or ADAPT techniques. J Neurointerv Surg. 2016 Nov;8(11):1123-1128. doi: 10.1136/neurintsurg-2015-012122. Epub 2015 Dec 14.
PubMed 26667250
Kim SH, Lee H, Kim SB, Kim ST, Baek JW, Heo YJ, Jeong HW, Kim HJ, Park JH, Kim JS, Jin SC. Hybrid mechanical thrombectomy for acute ischemic stroke using an intermediate aspiration catheter and Trevo stent simultaneously. J Clin Neurosci. 2020 Jun;76:9-14. doi: 10.1016/j.jocn.2020.04.079. Epub 2020 Apr 21.
PubMed 32327379
Lee J, Sheen SH, Jin SC, Choi Y, Hyun D, Shim YS, Kim T, Bae J, Kim CH, Kwon MY, Choi YJ, Hong D, Kim Y, Jeong EO, Kwon HJ, Lee Y, Lee J, Ryu S, Goh DH, Kim SY, Kwon SC, Lee JM, Koo HW, Jung Y, Kim J, Chang CH, Oh JS, Kim YW, Baek J, Kim KW; COMPETE Trials Investigators. Comparison of Clinical and Radiological Outcomes Between Suction Aspiration and Combination Methods of Mechanical Thrombectomy in Patients With Acute Cerebral Infarction: The COMPETE Trial. J Korean Med Sci. 2026 Apr 20;41(15):e164. doi: 10.3346/jkms.2026.41.e164.
PubMed 42011003

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06254755
Acronym / sponsor ID: HaeundaePaikH
Conditions: Acute Cerebral Ischemia Requiring for Mechanical Thrombectomy
Keywords: acute cerebral infarction, mechanical thrombectomy, suction aspiration, combination
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 1,132 participants (estimated)
Lead sponsor: Inje University Haeundae Paik HospitalUniversity, hospital or other
Collaborators: Korean Neuroendovascular Society
Study start: 1 Oct 2022 (actual)
Primary completion: 30 Jan 2027 (estimated)
Study completion: 30 Jan 2027 (estimated)
First posted: 12 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Alphabetic number of each hospital is an each hospital code.

Each investigator in the hospitals participated in COMPETE trials will write the competetrials spread sheet on google web.

This study should not enroll atherosclerotic tandem occlusion. Other etiologies such as cancer related stroke or dissection should not be enrolled in this study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Non-inferiority, open-labelled, randomization, case-controlled prospective multicenter trials

Arm	Type	Receives
suction aspiration group	Experimental	Device: mechanical thrombectomysuction aspiration group is based on a large bore catheter for thrombus removal under negative pressure of pump or manual syringe.
combination group	Active comparator	Device: mechanical thrombectomycombination group is based on a stent retrieval with a large bore catheter for thrombus removal under negative pressure of pump or manual syringe.

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mechanical thrombectomymechanical thrombectomy of acute ischemic stroke caused by major vessel occlusion of the anterior circulation has become an accepted procedure in the last decade.	Device	combination group, suction aspiration group

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.

5 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
Background: PubMed 29038080Goto 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.
Background: PubMed 26908591Massari 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.
Background: PubMed 29222393Maegerlein 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-2017-013558. Epub 2017 Dec 8.
Background: PubMed 28691137Lee 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.
Background: PubMed 28754806Brinjikji 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.
Background: PubMed 28702117Karanam 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.
Results publication: PubMed 30413831Maegerlein 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.
Results publication: PubMed 29628942Malisch 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 Local Aspiration and Retriever in the North American Solitaire Stent-Retriever Acute Stroke (NASA) Registry. Interv Neurol. 2018 Feb;7(1-2):26-35. doi: 10.1159/000480353. Epub 2017 Oct 11.
Results publication: PubMed 28271328Maegerlein C, Prothmann S, Lucia KE, Zimmer C, Friedrich B, Kaesmacher J. Intraprocedural Thrombus Fragmentation During Interventional Stroke Treatment: A Comparison of Direct Thrombus Aspiration and Stent Retriever Thrombectomy. Cardiovasc Intervent Radiol. 2017 Jul;40(7):987-993. doi: 10.1007/s00270-017-1614-4. Epub 2017 Mar 7.
Results publication: PubMed 34581737Lapergue B, Blanc R, Costalat V, Desal H, Saleme S, Spelle L, Marnat G, Shotar E, Eugene F, Mazighi M, Houdart E, Consoli A, Rodesch G, Bourcier R, Bracard S, Duhamel A, Ben Maacha M, Lopez D, Renaud N, Labreuche J, Gory B, Piotin M; ASTER2 Trial Investigators. Effect of Thrombectomy With Combined Contact Aspiration and Stent Retriever vs Stent Retriever Alone on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER2 Randomized Clinical Trial. JAMA. 2021 Sep 28;326(12):1158-1169. doi: 10.1001/jama.2021.13827.
Results publication: PubMed 26667250Delgado Almandoz JE, Kayan Y, Young ML, Fease JL, Scholz JM, Milner AM, Hehr TH, Roohani P, Mulder M, Tarrel RM. Comparison of clinical outcomes in patients with acute ischemic strokes treated with mechanical thrombectomy using either Solumbra or ADAPT techniques. J Neurointerv Surg. 2016 Nov;8(11):1123-1128. doi: 10.1136/neurintsurg-2015-012122. Epub 2015 Dec 14.
Results publication: PubMed 32327379Kim SH, Lee H, Kim SB, Kim ST, Baek JW, Heo YJ, Jeong HW, Kim HJ, Park JH, Kim JS, Jin SC. Hybrid mechanical thrombectomy for acute ischemic stroke using an intermediate aspiration catheter and Trevo stent simultaneously. J Clin Neurosci. 2020 Jun;76:9-14. doi: 10.1016/j.jocn.2020.04.079. Epub 2020 Apr 21.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Sung-Chul Jin, PhD principal investigator

Department of Neurosurgery, Inje University, Haeundae Paik Hospital

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing mechanical thrombectomy in people with Acute Cerebral Ischemia Requiring for Mechanical Thrombectomy, run by Inje University Haeundae Paik Hospital at 13 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiological outcome using modified TICI grade (mTICI) (time frame: time of control angiography after retrieval of thrombectomy devices). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06254755, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.