Clinical trial NCT06148675: Macrowire for IntracraNial Thrombectomy
Official title: MINT Registry : Macrowire for IntracraNial Thrombectomy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke, Acute Ischemic
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ability to deliver reperfusion catheter to the intracranial occlusion with macrowire alone (Yes/No)
timeFrame: Intraprocedure
Secondary outcomes:
measure: Time from vascular access to first intracranial pass (minutes)
timeFrame: Procedure duration
measure: Time from vascular access to recanalization (minutes)
timeFrame: Procedure duration
measure: Vessel dissection (Yes/No)
timeFrame: Intraprocedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Kaustubh Limaye, MD
role: PRINCIPAL_INVESTIGATOR
References:
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