Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy
Purpose
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
Condition
- Acute Ischemic Stroke AIS
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Balloon Guide Catheter |
Use of a balloon guide catheter in stroke thrombectomy. |
|
|
Other Conventional Guide Catheter |
Use of conventional (non-balloon guide) catheter in stroke thrombectomy. |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- University of South Florida