Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Stroke Cerebral Ischemia

Outcome Measures

Primary Outcomes (2)

Successful revascularization rate
Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure
Procedure end
Symptomatic intracranial haemorrhage rate
Symptomatic intracranial haemorrhage (ICH) as detected by CT/MRI and a clinical deterioration of NIHSS change ≥ 4
36 hours post procedure

Secondary Outcomes (8)

Successful revascularization rate with study device
Procedure
Successful revascularization rate on the first attempt with study device
Procedure
Procedure Time
Procedure
ENT rate
Procedure
Procedure Complications
Procedure through 90 days
+3 more secondary outcomes

Study Arms (1)

Q Revascularization System

EXPERIMENTAL

Device: Q Revascularization System

Interventions

Q Revascularization SystemDevice

Q Revascularization System for mechanical thrombectomy

Q Revascularization System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years or older.
Pre-stroke independent functional status in activities of daily living with mRS 0-1.

Sponsors & Collaborators

MIVI Neuroscience, Inc.
Industrylead

Study Sites (8)

University of South Florida

Tampa, Florida, 33620, United States

Cooper University Health Care

Camden, New Jersey, 08103, United States

University at Buffalo Neurosurgery

Buffalo, New York, 14208, United States

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

CHU Pellegrin

Bordeaux, 33000, France

CHU Urbains

Nancy, 54035, France

CHU Bicetre Paris

Paris, 94270, France

MeSH Terms

Conditions

StrokeBrain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

Christopher Cognard, PhD, MD
Hôpital Purpan
PRINCIPAL INVESTIGATOR
Lucas Elijovich, MD
University of Tennessee Health Sciences Center
PRINCIPAL INVESTIGATOR
Brian Jankowitz, MD
JFK University Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

121 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 18, 2020

Study Start

October 27, 2020

Actual (reported)

A Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (1)

Q Revascularization System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (1)

Q Revascularization System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations