Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy (2Guide)
Status
Enrolling
Conditions
Acute Ischemic Stroke AIS
Treatments
Other: Use of a Conventional (non-balloon) Guide Catheter
Other: Use of a Balloon Guide Catheter
Details and patient eligibility
About
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
Enrollment
100 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
100 participants in 2 patient groups
Balloon Guide Catheter
Other group
Description:
Use of a balloon guide catheter in stroke thrombectomy.
Treatment:
Other: Use of a Balloon Guide Catheter
Conventional Guide Catheter
Other group
Description:
Use of conventional (non-balloon guide) catheter in stroke thrombectomy.
Treatment:
Other: Use of a Conventional (non-balloon) Guide Catheter
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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