Macrowire for IntracraNial Thrombectomy

NCT06148675 | Completed

• 1 other identifier: 19347
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Acute Ischemic

Outcome Measures

Primary Outcomes (1)

• Ability to deliver reperfusion catheter to the intracranial occlusion with macrowire alone (Yes/No)

  Intraprocedure

Secondary Outcomes (3)

• Time from vascular access to first intracranial pass (minutes)

  Procedure duration

• Time from vascular access to recanalization (minutes)

  Procedure duration

• Vessel dissection (Yes/No)

  Intraprocedure

Study Arms (1)

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.

Other: No Intervention

Interventions

No Intervention OTHER

No intervention,data collection

Participants with emergent large vessel occlusion undegoing intracranial mechanical thromebctomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects aged 18-85 years will be identified once they undergo mechanical thrombectomy for large vessel occlusion where delivery of reperfusion catheter over macrowire alone was performed.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (6)

• 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.

  PMID: 25517348 BACKGROUND

• 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.

  PMID: 25671798 BACKGROUND

• 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.

  PMID: 28946832 BACKGROUND

• 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.

  PMID: 30037944 BACKGROUND

• 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.

  PMID: 28963362 BACKGROUND

• 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.

  PMID: 28768818 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kaustubh Limaye, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor Of Neurology, Neurological Surgery and Radiology

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: May 25, 2023
• Primary Completion: March 31, 2025
• Study Completion: July 1, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)