Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy

NCT ID: NCT07085390

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-27

Study Completion Date

2028-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Acute Ischemic Stroke AIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Balloon Guide Catheter

Use of a balloon guide catheter in stroke thrombectomy.

Group Type OTHER

Use of a Balloon Guide Catheter

Intervention Type OTHER

Use of a balloon guide catheter in stroke thrombectomy.

Conventional Guide Catheter

Use of conventional (non-balloon guide) catheter in stroke thrombectomy.

Group Type OTHER

Use of a Conventional (non-balloon) Guide Catheter

Intervention Type OTHER

Use of a conventional (non-balloon) guide catheter in stroke thrombectomy.

Interventions

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Use of a Balloon Guide Catheter

Use of a balloon guide catheter in stroke thrombectomy.

Intervention Type OTHER

Use of a Conventional (non-balloon) Guide Catheter

Use of a conventional (non-balloon) guide catheter in stroke thrombectomy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Patient is undergoing a stroke thrombectomy procedure at the enrolling hospital
* Patient or the legally authorized representative are able to provide signed informed cosent for the study
* Patient is not enrolled in another clinical trial that may interfere with the results or interpretation of this study
* Identification of a Large Vessel Occlusion (LVO) on imaging

Exclusion Criteria

* Lack of signed informed consent from the patient or legally authorized representative
* Spontanous recanalization or any other reason in which the mechanical thrombectomy procedure would be terminated
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of South Florida (USF)

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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USF QAQI

Role: primary

813-974-7454

Other Identifiers

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007664

Identifier Type: -

Identifier Source: org_study_id

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