Flow Arrest Safety and Technical Success With Balloon Guide Catheters

Completed

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT04416659

Run by

Medtronic Neurovascular Clinical Affairs

People needed

52

Starts

2021-01-12

Expected to finish

2021-10-27

Last updated by the study team

2022-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• BNI (St. Joseph's Hospital-Dignity Health) — Phoenix, Arizona, United States
• Swedish-RIACO — Englewood, Colorado, United States
• Baptist Health Jacksonville — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• KUMC — Kansas City, Kansas, United States
• UMass Medical School — Worcester, Massachusetts, United States
• University of Missouri — Columbia, Missouri, United States
• Ft Sanders Regional Medical Center — Knoxville, Tennessee, United States
• Carilion Clinic — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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