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

• Sponsor: University at Buffalo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05074186
• Collaborator: University at Buffalo Jacobs Institute (Other)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Device: neurological thrombectomy device is an investigational device.	N/A

Detailed Description

The neurological thrombectomy device is an investigational device

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke
• Actual Study Start Date: Jun 8, 2021
• Anticipated Primary Completion Date: Dec 15, 2022
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: neurological thrombectomy device Revascularization device is an investigational device.	Device: neurological thrombectomy device is an investigational device.; Revascularization device is an investigational device.

Outcome Measures

Primary Outcome Measures

1. Evaluate technical efficacy outcomes with radiographical measurements [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 [day 1]

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

Secondary Outcome Measures

1. Evaluate technical efficacy outcomes with radiographical measurements [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 [90 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	kaledia Health/Buffalo General Medical Center/GVI	Buffalo	New York	United States	14203

Sponsors and Collaborators

• University at Buffalo
• University at Buffalo Jacobs Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adnan H. Siddiqui, Principal Investigator, University at Buffalo
• ClinicalTrials.gov Identifier: NCT05074186
• Other Study ID Numbers: D001-PRT21-026
• First Posted: Oct 12, 2021
• Last Update Posted: May 23, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia

Study Results

No Results Posted as of May 23, 2022