Balloon guide catheter versus conventional guide catheter for clot removal in ischemic stroke
Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy
NA · University of South Florida · NCT07085390
This study will test whether a balloon guide catheter or a conventional guide catheter works better for adults having a thrombectomy to treat an acute ischemic stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of South Florida (other) |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT07085390 on ClinicalTrials.gov |
What this trial studies
Adults with an acute ischemic stroke due to a large vessel occlusion who are undergoing a mechanical thrombectomy at the enrolling hospital will have their procedure performed using either a balloon guide catheter or a conventional (non-balloon) guide catheter. Routine clinical data, imaging, and procedural details will be collected to compare metrics such as time to restore blood flow, technical success, and clinical outcomes. Participants receive standard-of-care thrombectomy and provide consent and some questionnaire information; no additional experimental treatment is given beyond the catheter type. The trial aims to clarify the technical, clinical, and procedural differences between the two catheter approaches.
Who should consider this trial
Good fit: Ideal candidates are adults (age 18 or older) with a confirmed large vessel occlusion who are undergoing a thrombectomy at the enrolling hospital and can provide informed consent or have a legally authorized representative do so.
Not a fit: Patients without a large vessel occlusion, those who have spontaneous recanalization before the procedure, or those unable to provide consent are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could identify a catheter approach that shortens time to reopen the blocked artery, improves chances of recovery, and reduces procedure-related complications.
How similar studies have performed: Previous observational studies and some randomized data suggest balloon guide catheters may improve first-pass recanalization and reduce distal embolization, but findings have been mixed and definitive head-to-head evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampa, Florida
- University of South Florida (USF) — Tampa, Florida, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Ischemic Stroke AIS, Ischemic Stroke, Thrombectomy