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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

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

ArmDescriptionAssigned Intervention
Other
Balloon Guide Catheter 		Use of a balloon guide catheter in stroke thrombectomy.
  • Other: Use of a 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.
  • Other: Use of a Conventional (non-balloon) Guide Catheter
    Use of a conventional (non-balloon) guide catheter in stroke thrombectomy.

Recruiting Locations

University of Texas Health - Houston
Houston, Texas 77030
Contact:
Sunil Sheth Associate Professor, MD
832-325-7080
sunil.a.sheth@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
University of South Florida

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.