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OpenTrials
Completed

NCT Number: NCT05074186

Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke

The Jacobs Institute is participating in a Sponsor Investigator study designed to collect prospective clinical evidence to evaluate the use of a neurological thrombectomy device for clot retrieval in acute ischemic patients

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

kaledia Health/Buffalo General Medical Center/GVI

Buffalo, New York, 14203, United States

About this study

The neurological thrombectomy device is an investigational device

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

at least 18 years of age at time of consent Has baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 8; Able to be treated within 8 hours of stroke symptom onset or Last Known Normal (LKN);

Exclusion criteria

Cannot provide consent or legally authorized representative not available to provide consent

Treatment and study plan

neurological thrombectomy device is an investigational device.

Device

Revascularization device is an investigational device.

Primary outcomes

  1. Evaluate technical efficacy outcomes with radiographical measurements

    Time frame: Day 1

    The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score

  2. outcomes with radiographical measurements

    Time frame: day 1

    The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score

Secondary outcomes

  1. Evaluate technical efficacy outcomes with radiographical measurements

    Time frame: Day 3

    The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score

  2. Evaluate technical efficacy outcomes with radiographical measurements

    Time frame: 90 days

    The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score

Sponsors and collaborators

Lead sponsor

Jacobs institute

Other

Collaborators

  • University at Buffalo

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2021
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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