MINT: Macrowire for IntracraNial Thrombectomy
Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06148675
Collaborator
(none)
200
1
35.2
5.7
Study Details
Study Description
Brief Summary
The aim of this study is to develop a multicenter registry 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
MINT Registry : Macrowire for IntracraNial Thrombectomy Registry
Actual Study Start Date
:
May 25, 2023
Anticipated Primary Completion Date
:
May 1, 2025
Anticipated Study Completion Date
:
May 1, 2026
Arms and Interventions
| Arm | 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. |
Other: No Intervention
No intervention, prospective data collection
|
Outcome Measures
Primary Outcome Measures
- Ability to deliver reperfusion catheter to the intracranial occlusion with macrowire alone (Yes/No) [Intraprocedure]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Methodist Hospital | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
Investigators
- Principal Investigator: Kaustubh Limaye, MD, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Erratum In: N Engl J Med. 2015 Jan 22;372(4):394.
- 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.
- 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. Erratum In: J Neurointerv Surg. 2021 Jun;13(6):e12.
- 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.
- 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.
Responsible Party:
Kaustubh Limaye,
Assistant Clinical Professor Of Neurology, Neurological Surgery and Radiology,
Indiana University
ClinicalTrials.gov Identifier:
NCT06148675
Other Study ID Numbers:
- 19347
First Posted:
Nov 28, 2023
Last Update Posted:
Nov 28, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: