Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07085390
Status
Recruiting
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Conditions

  • Acute Ischemic Stroke AIS

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Use of a Balloon Guide Catheter — OTHER
    Use of a balloon guide catheter in stroke thrombectomy.
  • Use of a Conventional (non-balloon) Guide Catheter — OTHER
    Use of a conventional (non-balloon) guide catheter in stroke thrombectomy.

Study Details

The purpose of this clinical trial is to study the two main types of approaches used in stroke thrombectomy and to investigate if one approach is more effective than the other, as this is currently not known. This study will be conducted in adults who have been diagnosed with an acute ischemic stroke and who are undergoing a thrombectomy for the treatment of their stroke. The main questions it aims to answer are: * Does the use of a balloon guide catheter versus a conventional guide catheter lower the time needed to restore blood flow in the blocked vessel in the brain * To help researchers better understand the technical, clinical, and procedural outcomes associated with using a balloon guide catheter versus a conventional guide catheter in stroke thrombectomy Participants will be asked to * Share their medical history and imaging data that is collected as part of their routine medical care * Undergo a mechanical thrombectomy as part of their routine medical care * Answer some questions about their neurological functioning at 3 months (90 days) post hospitalization

Key Dates

Start date
Aug 27, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Balloon Guide Catheter
    Use of a balloon guide catheter in stroke thrombectomy.
  • Other: Conventional Guide Catheter
    Use of conventional (non-balloon guide) catheter in stroke thrombectomy.

Primary Outcome Measure

TICI Grading Scale Score [ Time Frame: Participant duration is 90 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of South Florida (USF)TampaFlorida33606
USF QAQI
[email protected]
813-974-7454
Maxim Mokin, MD/ PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of South Florida (USF)· Tampa, FL

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