CClinicalTrials.gg
RecruitingNCT070853902GuideUpdated Jul 22, 2026

Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy

An interventional study of Use of a Balloon Guide Catheter and Use of a Conventional (non-balloon) Guide Catheter in Acute Ischemic Stroke AIS, sponsored by University of South Florida. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by University of South Florida · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Acute Ischemic Stroke AIS

Browse trials for

Keywords

  • Ischemic Stroke
  • Thrombectomy
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.

This study's planned enrollment of 186 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
186 participants (estimated)

Study arms

  • Other
    Balloon Guide Catheter

    Use of a balloon guide catheter in stroke thrombectomy.

    Other: Use of a Balloon Guide Catheter

  • Other
    Conventional Guide Catheter

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

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

Interventions

  • OtherUse of a Balloon Guide Catheter

    Use of a balloon guide catheter in stroke thrombectomy.

  • OtherUse of a Conventional (non-balloon) Guide Catheter

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

06

What researchers measure

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.

    Time frame: Participant duration is 90 days.

Secondary outcomes

  1. Procedural Outcomes

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

    Time frame: Participant duration is 90 days.

  2. Number of Participants with Treatment Related Adverse Effects

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

    Time frame: Participant duration is 90 days.

07

Study locations

2 of 2 sites recruiting
  • University of South Florida (USF)
    Tampa, Florida 33606, United States
    • USF QAQI · Contact · qa-qi@usf.edu · 813-974-7454
    • Maxim Mokin, MD/ PhD · Principal investigator
    Recruiting
  • University of Texas Health - Houston
    Houston, Texas 77030, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared with participants as both catheters are routinely used in acute ischemic stroke thrombectomy. The decision to use a balloon guide versus a conventional guide catheter is usually left to the discretion of the operator.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07085390
Lead sponsor
University of South Florida
Responsible party
Sponsor
First posted
Jul 25, 2025
Start date
Aug 27, 2025
Primary completion
Aug 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
Jul 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion