Brief Summary

This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.

Trial Health

Monitor

Trial Health Score

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

Enrollment

182

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Apr 2016

Geographic Reach

1 country

40 active sites

Status

terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

October 21, 2015

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed

5 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2017

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

September 19, 2018

Completed

Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

October 21, 2015

Results QC Date

August 23, 2018

Last Update Submit

May 13, 2019

Conditions

Stroke, Acute Cerebral Infarction

Keywords

endovascularendovascular procedureMechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Day 90

Secondary Outcomes (1)

Count of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence
day 90

Other Outcomes (6)

Count of Participants With Symptomatic Intracranial Hemorrhage (Primary Safety Outcome)
36 hours
Parenchymal Hematoma Type 2 (Safety Outcome)
24 (±6) hours
Infarct Volume (Imaging Outcome)
24 (+/- 6) hours
+3 more other outcomes

Study Arms (2)

endovascular thrombectomy therapy

ACTIVE COMPARATOR

Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile. Devices approved for use in DEFUSE 3: * Trevo Retriever * Solitaire™ FR Revascularization Device * Penumbra thrombectomy system * Covidien MindFrame Capture Revascularization Device

Procedure: Endovascular ThrombectomyDevice: Trevo RetrieverDevice: Solitaire™ FR Revascularization DeviceDevice: Penumbra thrombectomy systemDevice: Covidien MindFrame Capture Revascularization Device

Medical Management

NO INTERVENTION

standard medical therapy alone

Interventions

Endovascular ThrombectomyPROCEDURE

Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.