Flow Arrest Safety and Technical Success With Balloon Guide Catheters

Completed

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT04416659
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

Brief Summary

The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing temporary arrest of blood flow.

Detailed Description

This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion.

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Study Start: 2021-01-12
• Primary Completion: 2021-10-27
• Study Completion: 2021-10-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation with associated symptoms
• Adult patient willing to provide Informed Consent
• Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6

Exclusion Criteria

• Posterior circulation stroke
• Tandem occlusions
• Cervical carotid stenosis
• Participating in another clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance Evaluation	Completion of procedure	Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment
Safety Evaluation	Hospital discharge or 7 days	Incidence of device-related adverse events

Trial Locations

Locations (9)

UMass Medical School; 🇺🇸 Worcester, Massachusetts, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States

Swedish-RIACO; 🇺🇸 Englewood, Colorado, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

BNI (St. Joseph's Hospital-Dignity Health); 🇺🇸 Phoenix, Arizona, United States

KUMC; 🇺🇸 Kansas City, Kansas, United States

Baptist Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Ft Sanders Regional Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States