Balloon vs Conventional Guide Catheters for Stroke
(2Guide Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two methods used during stroke thrombectomy, a procedure that clears blocked blood vessels in the brain after a stroke. The researchers aim to determine if a balloon guide catheter (a type of medical device) restores blood flow more quickly than a conventional guide catheter. Participants will share their medical history and undergo the thrombectomy as part of their regular care. Individuals who have experienced an acute ischemic stroke and are scheduled for a thrombectomy may be suitable for this trial. As an unphased trial, this study allows participants to contribute to important research that could enhance stroke treatment methods.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these catheter techniques are safe for stroke thrombectomy?
Studies have shown that both balloon guide catheters and conventional guide catheters are generally safe for use in stroke thrombectomy, a procedure to remove a blood clot from a blood vessel in the brain. Research indicates that balloon guide catheters can improve blood flow during the procedure. However, some studies noted they might not always lead to better recovery afterward.
For conventional guide catheters, research suggests they are just as safe as balloon guide catheters. One study found that when used with certain techniques, conventional guide catheters performed equally well without increasing risks.
In summary, both types of catheters have been used safely in medical procedures, with no major safety issues reported. Participants in studies tolerated these treatments well, with no significant adverse events linked to either catheter type.12345Why are researchers excited about this trial?
Researchers are excited about comparing balloon guide catheters to conventional guide catheters in stroke treatment. Balloon guide catheters are unique because they can temporarily block blood flow during a thrombectomy, potentially improving the removal of clots and reducing the risk of stroke-related damage. Conventional guide catheters don't have this feature, so understanding whether the balloon technique enhances outcomes could lead to more effective stroke interventions.
What evidence suggests that this trial's treatments could be effective for stroke?
This trial will compare the use of a Balloon Guide Catheter with a Conventional Guide Catheter in stroke thrombectomy. Research has shown that a balloon guide catheter can sometimes improve blood flow in stroke treatment, with some studies indicating better recovery in patients with sudden strokes. However, results are mixed, as other studies suggest it might not always enhance recovery. Regular guide catheters also perform well, but a direct comparison of their effectiveness is still needed. Both methods are commonly used, and this trial aims to determine if one is superior.24567
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are having a stroke thrombectomy at the enrolling hospital, can give consent, and have a large vessel blockage on imaging. They shouldn't be in another study that could affect this one's results.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a mechanical thrombectomy using either a balloon guide catheter or a conventional guide catheter
Follow-up
Participants are monitored for safety and effectiveness, including neurological assessments at 3 months post hospitalization
What Are the Treatments Tested in This Trial?
Interventions
- Balloon Guide Catheter
- Conventional Guide Catheter
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Florida
Lead Sponsor