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NCT Number: NCT07085390

Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy

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

Recruiting

Interested in participating?

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Key information

Conditions

Acute Ischemic Stroke AIS Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida (USF), Tampa, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of a Balloon Guide Catheter

Other

Use of a balloon guide catheter in stroke thrombectomy.

Use of a Conventional (non-balloon) Guide Catheter

Other

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

Primary outcomes

  1. TICI Grading Scale Score

    Time frame: 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 outcomes

  1. Procedural Outcomes

    Time frame: Participant duration is 90 days.

    Metrics associated with a standard of care thrombectomy procedure, such as length of procedure, will be collected.

  2. Number of Participants with Treatment Related Adverse Effects

    Time frame: Participant duration is 90 days.

    Collection of data related to clincial and safety outcomes such as presence of a bleed.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Acronym: 2Guide

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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