Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of a Balloon Guide Catheter, Use of a Conventional (non-balloon) Guide Catheter.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke AIS. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Other Use of a Balloon Guide Catheter
Use of a balloon guide catheter in stroke thrombectomy. - Other Use of a Conventional (non-balloon) Guide Catheter
Use of a conventional (non-balloon) guide catheter in stroke thrombectomy.
Primary outcome measures
- TICI Grading Scale Score [Time frame: Participant duration is 90 days.]
Secondary outcome measures (2)
- Procedural Outcomes [Time frame: Participant duration is 90 days.]
- Number of Participants with Treatment Related Adverse Effects [Time frame: Participant duration is 90 days.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 2 centers
- University of South Florida (USF) — Tampa
- University of Texas Health - Houston — Houston
Identifiers
NCT: NCT07085390 · 007664