- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06148675
Macrowire for IntracraNial Thrombectomy (MINT)
November 6, 2025 updated by: Kaustubh Limaye, Indiana University
MINT Registry : Macrowire for IntracraNial Thrombectomy
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
105
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
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Methodist Hospital
-
-
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
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.
Description
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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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,data collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ability to deliver reperfusion catheter to the intracranial occlusion with macrowire alone (Yes/No)
Time Frame: Intraprocedure
|
Intraprocedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time from vascular access to first intracranial pass (minutes)
Time Frame: Procedure duration
|
Procedure duration
|
|
Time from vascular access to recanalization (minutes)
Time Frame: Procedure duration
|
Procedure duration
|
|
Vessel dissection (Yes/No)
Time Frame: Intraprocedure
|
Intraprocedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kaustubh Limaye, MD, Indiana University
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
May 25, 2023
Primary Completion (Actual)
March 31, 2025
Study Completion (Actual)
July 1, 2025
Study Registration Dates
First Submitted
November 20, 2023
First Submitted That Met QC Criteria
November 20, 2023
First Posted (Actual)
November 28, 2023
Study Record Updates
Last Update Posted (Actual)
November 10, 2025
Last Update Submitted That Met QC Criteria
November 6, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All data will be de-identified
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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