Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy
ConditionAcute Ischemic Stroke AIS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Use of a Balloon Guide Catheter
Other interventionUse of a balloon guide catheter in stroke thrombectomy.
Use of a Conventional (non-balloon) Guide Catheter
Other interventionUse of a conventional (non-balloon) guide catheter in stroke thrombectomy.
Treatment groups
186 Participants
are divided into 2 treatment groupsGroup A: Balloon Guide CatheterOther 1 intervention
Group B: Conventional Guide CatheterOther 1 intervention
Trial outcomes
Primary outcomes
1
TICI Grading Scale Score
Use of a mTICI grading scale to look at the degree to which the vessel has been opened during a mechanical thrombectomy.
Time frame
Participant duration is 90 days.Secondary outcomes
1
Procedural Outcomes
Metrics associated with a standard of care thrombectomy procedure, such as length of procedure, will be collected.
Time frame
Participant duration is 90 days.2
Number of Participants with Treatment Related Adverse Effects
Collection of data related to clincial and safety outcomes such as presence of a bleed.
Time frame
Participant duration is 90 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov