Acute Ischemic Stroke AIS2GuideNCT07085390
Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy
A study testing Use of a Balloon Guide Catheter and Use of a Conventional (non-balloon) Guide Catheter in people with Acute Ischemic Stroke AIS, run by University of South Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke AIS
- What is being tested?
- Use of a Balloon Guide Catheter and Use of a Conventional (non-balloon) Guide Catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Aug 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Texas Health - Houston
Houston, Texas, 77030
Sunil Sheth Associate Professor, MD, 832-325-7080, sunil.a.sheth@uth.tmc.edu
Javier Gomez-Farias Associate Professor, MD, (832) 325-7080, Javier.GomezFarias@uth.tmc.edu
- Recruiting
University of South Florida (USF)
Tampa, Florida, 33606
USF QAQI, 813-974-7454, qa-qi@usf.edu
Maxim Mokin, MD/ PhD
About this study
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
Read more
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
- Being tested
- Use of a Balloon Guide Catheter, Use of a Conventional (non-balloon) Guide Catheter
- Keywords
- Ischemic Stroke, Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a Balloon Guide CatheterOther
Use of a balloon guide catheter in stroke thrombectomy.
Use of a Conventional (non-balloon) Guide CatheterOther
Use of a conventional (non-balloon) guide catheter in stroke thrombectomy.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Guide Catheter | Other | Use of a balloon guide catheter in stroke thrombectomy. Receives: Other: Use of a Balloon Guide Catheter |
| Conventional Guide Catheter | Other | Use of conventional (non-balloon guide) catheter in stroke thrombectomy. Receives: Other: Use of a Conventional (non-balloon) Guide Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participant duration is 90 days.
Secondary outcomes (2)
Procedural Outcomes
Metrics associated with a standard of care thrombectomy procedure, such as length of procedure, will be collected.
Measured: Participant duration is 90 days.
Number of Participants with Treatment Related Adverse Effects
Collection of data related to clincial and safety outcomes such as presence of a bleed.
Measured: Participant duration is 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start27 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke AISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085390
- Sponsor's protocol ID
- 007664
- Acronym
- 2Guide
- Status last verified
- Jul 2026
- First submitted
- 16 May 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy
- ClinicalTrials.gov ID
- NCT07085390
- Acronym / sponsor ID
- 2Guide / 007664
- Conditions
- Acute Ischemic Stroke AIS
- Keywords
- Ischemic Stroke, Thrombectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Guide Catheter | Other | Other: Use of a Balloon Guide CatheterUse of a balloon guide catheter in stroke thrombectomy. |
| Conventional Guide Catheter | Other | Other: Use of a Conventional (non-balloon) Guide CatheterUse of conventional (non-balloon guide) catheter in stroke thrombectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of a Balloon Guide CatheterUse of a balloon guide catheter in stroke thrombectomy. | Other | Balloon Guide Catheter |
| Use of a Conventional (non-balloon) Guide CatheterUse of a conventional (non-balloon) guide catheter in stroke thrombectomy. | Other | Conventional Guide Catheter |
Primary outcome
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.
2 secondary outcomes
Procedural Outcomes
Time frame: Participant duration is 90 days.
Number of Participants with Treatment Related Adverse Effects
Time frame: Participant duration is 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of a Balloon Guide Catheter and Use of a Conventional (non-balloon) Guide Catheter in people with Acute Ischemic Stroke AIS, run by University of South Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TICI Grading Scale Score (time frame: Participant duration is 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.