NCT05074186

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

September 29, 2021

Last Update Submit

September 8, 2025

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

  • Evaluate technical efficacy outcomes with radiographical measurements

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

    Day 1

  • outcomes with radiographical measurements

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

    day 1

Secondary Outcomes (2)

  • Evaluate technical efficacy outcomes with radiographical measurements

    Day 3

  • Evaluate technical efficacy outcomes with radiographical measurements

    90 days

Study Arms (1)

neurological thrombectomy device

EXPERIMENTAL

Revascularization device is an investigational device.

Device: neurological thrombectomy device is an investigational device.

Interventions

neurological thrombectomy device is an investigational device.DEVICE

Revascularization device is an investigational device.

neurological thrombectomy device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kaledia Health/Buffalo General Medical Center/GVI

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

June 8, 2021

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)