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BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke

NCT05361187 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 171

Last updated 2025-01-07

No results posted yet for this study

Summary

Evaluation of the safety and performance of the BOBBY™ Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). To prevent clot particles migrating in other parts of the brain circulation during the thrombectomy, balloon guiding catheters are inserted. The aim of the study is to evaluate the safety and performance of the balloon guide catheter BOBBY™ by collecting information from patients, treated with a mechanical thrombectomy and the balloon guide catheter (BOBBY™) after acute ischemic stroke

Conditions

  • Cerebrovascular Stroke

Interventions

DEVICE

BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device

The BOBBY™ BGC used during a mechanical thrombectomy procedure (stent retriever alone, contact aspiration alone or stent retriever and contact aspiration) and according to the instruction for use (IFU).

Sponsors & Collaborators

  • Microvention-Terumo, Inc.

    lead INDUSTRY

Principal Investigators

  • Tobias Boeckh-Behrens, MD · Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität

  • Patricia Boyer · Microvention-Terumo, Inc.

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2023-09-30
Completion
2023-12-30

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361187 on ClinicalTrials.gov