Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke AIS

• Registration Number: NCT07085390
• Lead Sponsor: University of South Florida

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2025-05-16
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Primary Completion: 2027-07
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TICI Grading Scale Score	Participant duration is 90 days.	Use of a mTICI grading scale to look at the degree to which the vessel has been opened during a mechanical thrombectomy.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Treatment Related Adverse Effects	Participant duration is 90 days.	Collection of data related to clincial and safety outcomes such as presence of a bleed.
Procedural Outcomes	Participant duration is 90 days.	Metrics associated with a standard of care thrombectomy procedure, such as length of procedure, will be collected.

Trial Locations

Locations (1)

University of South Florida (USF); 🇺🇸 Tampa, Florida, United States