Recruiting

Balloon Guide Catheter vs. Conventional Guide Catheter

Sponsor:

University of South Florida

Code:

NCT07085390

Conditions

Acute Ischemic Stroke AIS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of a Balloon Guide Catheter

Use of a Conventional (non-balloon) Guide Catheter

Study Details

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

Conditions

Acute Ischemic Stroke AIS

Study ID

NCT07085390

Start date

Aug 27, 2025

Status verified date

Jul, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Use of a Balloon Guide Catheter

Use of a balloon guide catheter in stroke thrombectomy.

Use of a Conventional (non-balloon) Guide Catheter

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

Primary outcome measure

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

Central Contacts and Locations

Locations

University of South Florida (USF)

Recruiting

Tampa, Florida, United States, 33606

Contacts

USF QAQI

813-974-7454qa-qi@usf.edu

Principal Investigator:

Maxim Mokin, MD/ PhD

University of Texas Health - Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Sunil Sheth Associate Professor, MD

832-325-7080sunil.a.sheth@uth.tmc.edu

Javier Gomez-Farias Associate Professor, MD

(832) 325-7080Javier.GomezFarias@uth.tmc.edu

Principal Investigator:

Sunil Sheth, MD

More Information

Sponsor

University of South Florida

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Ischemic Stroke
  • Thrombectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-07-22.