Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07085390

Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy

Led by University of South Florida · Updated on 2025-09-17

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two main methods used in stroke thrombectomy to find out if one is more effective than the other. This study focuses on adults diagnosed with acute ischemic stroke who are undergoing a thrombectomy procedure. The main goals are to see if using a balloon guide catheter instead of a conventional guide catheter reduces the time needed to restore blood flow in the brain and to better understand the technical, clinical, and procedural outcomes associated with each method. Participants will receive either a balloon guide catheter or a conventional guide catheter during their stroke thrombectomy as part of their routine medical care. The study is randomized and double-blinded to fairly compare these two approaches. There are two study groups: one using the balloon guide catheter and the other using the conventional catheter. During the study, participants will share their medical history and imaging data collected during their care. They will also answer questions about their neurological function 90 days after hospitalization. Researchers will assess outcomes using the TICI Grading Scale Score and monitor procedural outcomes and treatment-related adverse effects over this 90-day period.

CONDITIONS

Brief Title

Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patient is undergoing a stroke thrombectomy procedure at the enrolling hospital
  • Patient or legally authorized representative can provide signed informed consent
  • Patient is not enrolled in another clinical trial that may interfere with this study
  • Identification of a Large Vessel Occlusion (LVO) on imaging
Not Eligible

You will not qualify if you...

  • Lack of signed informed consent from the patient or legally authorized representative
  • Spontaneous recanalization or any other reason causing termination of the mechanical thrombectomy procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Treatment

Duration - Procedure day

Participants undergo stroke thrombectomy using either a balloon guide catheter or a conventional guide catheter.

1 procedure visit (in-person)

Follow-up

Duration - Up to 90 days

Participants are monitored for clinical outcomes and any treatment-related adverse effects after the procedure.

Follow-up visits as scheduled for up to 90 days

Trial Site Locations

Total: 1 location

1

University of South Florida (USF)

Tampa, Florida, United States, 33606

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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