Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy

NCT07085390 | Recruiting DMC

• 1 other identifier: 007664
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Ischemic Stroke; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• TICI Grading Scale Score

  Use of a mTICI grading scale to look at the degree to which the vessel has been opened during a mechanical thrombectomy.

  Participant duration is 90 days.

Secondary Outcomes (2)

• Procedural Outcomes

  Participant duration is 90 days.

• Number of Participants with Treatment Related Adverse Effects

  Participant duration is 90 days.

Study Arms (2)

Balloon Guide Catheter

OTHER

Use of a balloon guide catheter in stroke thrombectomy.

Other: Use of a Balloon Guide Catheter

Conventional Guide Catheter

OTHER

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

Other: Use of a Conventional (non-balloon) Guide Catheter

Interventions

Use of a Balloon Guide Catheter OTHER

Use of a balloon guide catheter in stroke thrombectomy.

Balloon Guide Catheter

Use of a Conventional (non-balloon) Guide Catheter OTHER

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

Conventional Guide Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida (USF)

Tampa, Florida, 33606, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: July 25, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)