Macrowire for IntracraNial Thrombectomy

NCT ID: NCT06148675

Last Updated: 2025-11-10

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

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-25

Study Completion Date

2025-07-01

Brief Summary

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The aim of this study is to develop a multicenter database of patient data and outcomes for patients undergoing intracranial thrombectomy for acute ischemic stroke secondary to emergent large vessel occlusion with delivery of reperfusion catheter over a novel macrowire (Aristotle Colossus) to perform intracranial mechanical thrombectomy.

Detailed Description

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Conditions

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Stroke, Acute Ischemic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants with emergent large vessel occlusion undegoing intracranial mechanical thromebctomy

Participants with emergent large vessel occlusion undergoing intracranial mechanical thrombectomy where the reperfusion catheter was delivered over a macrowire to perform thrombectomy.

No Intervention

Intervention Type OTHER

No intervention,data collection

Interventions

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No Intervention

No intervention,data collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Age \>18-85 years Time of onset \< 24 hours Acute stroke patient with NIHSS \>6 CT-ASPECTS ≥ 6 Proven intracranial occlusion - (ICA-T, M1) Modified Rankin score: 0-2

Exclusion Criteria

Age \<18 years or \>85 years Unknown time of onset NIHSS \< 5 CT ASPECTS \<5 Pre-stroke morbidity, modified Rankin score \> 2 Tandem occlusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Kaustubh Limaye

Assistant Clinical Professor Of Neurology, Neurological Surgery and Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaustubh Limaye, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University Methodist Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama a Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17.

Reference Type BACKGROUND
PMID: 25517348 (View on PubMed)

Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.

Reference Type BACKGROUND
PMID: 25671798 (View on PubMed)

Albers GW, Lansberg MG, Kemp S, Tsai JP, Lavori P, Christensen S, Mlynash M, Kim S, Hamilton S, Yeatts SD, Palesch Y, Bammer R, Broderick J, Marks MP. A multicenter randomized controlled trial of endovascular therapy following imaging evaluation for ischemic stroke (DEFUSE 3). Int J Stroke. 2017 Oct;12(8):896-905. doi: 10.1177/1747493017701147. Epub 2017 Mar 24.

Reference Type BACKGROUND
PMID: 28946832 (View on PubMed)

Turk AS, Frei D, Fiorella D, Mocco J, Baxter B, Siddiqui A, Spiotta A, Mokin M, Dewan M, Quarfordt S, Battenhouse H, Turner R, Chaudry I. ADAPT FAST study: a direct aspiration first pass technique for acute stroke thrombectomy. J Neurointerv Surg. 2018 Jul;10(Suppl 1):i4-i7. doi: 10.1136/neurintsurg-2014-011125.rep.

Reference Type BACKGROUND
PMID: 30037944 (View on PubMed)

Hesse AC, Behme D, Kemmling A, Zapf A, Grosse Hokamp N, Frischmuth I, Maier I, Liman J, Tsogkas I, Buhk JH, Tran J, Fiehler J, Mpotsaris A, Schramm P, Berlis A, Knauth M, Psychogios MN. Comparing different thrombectomy techniques in five large-volume centers: a 'real world' observational study. J Neurointerv Surg. 2018 Jun;10(6):525-529. doi: 10.1136/neurintsurg-2017-013394. Epub 2017 Sep 28.

Reference Type BACKGROUND
PMID: 28963362 (View on PubMed)

Heit JJ, Wong JH, Mofaff AM, Telischak NA, Dodd RL, Marks MP, Do HM. Sofia intermediate catheter and the SNAKE technique: safety and efficacy of the Sofia catheter without guidewire or microcatheter construct. J Neurointerv Surg. 2018 Apr;10(4):401-406. doi: 10.1136/neurintsurg-2017-013256. Epub 2017 Aug 2.

Reference Type BACKGROUND
PMID: 28768818 (View on PubMed)

Other Identifiers

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19347

Identifier Type: -

Identifier Source: org_study_id