Aureva Transcranial Ultrasound Device With tPA in Patients With Acute Ischemic Stroke (TRUST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03519737|
Recruitment Status : Active, not recruiting
First Posted : May 9, 2018
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Device: tPA in combination with the Sonolysis Headframe (TUS) Device: tPA in combination with the Sonolysis Headframe (Sham TUS)||Not Applicable|
The primary objective of this study is to assess the safety and efficacy of TUS using the Sonolysis Headframe in combination with systemic tPA (Treatment group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke.
Number of Subjects Required:
Lead-in Phase: 40 subjects in the U.S.; Primary Phase: 556 total enrolled subjects (278 per arm)
Number of Study Centers:
Lead-in Phase: Up to 20 Institutions in U.S.; Primary Phase: Up to 70 Institutions worldwide
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||596 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Sham control and active insonation. During lead-in phase for the first 40 subjects, only active insonation will be programmed.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Blinding is achieved through operator entry of a randomization variable obtained from IWRS at the time of enrollment and randomization. This randomization variable (A or B), the meaning of which is blinded to the operator, is entered into the control box and determines the mode of the device as either active insonation or sham insonation.|
|Official Title:||A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of the Aureva Transcranial Ultrasound Device With Tissue Plasminogen Activator in Patients With Acute Ischemic Stroke (TRUST)|
|Actual Study Start Date :||August 17, 2018|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Sham Comparator: Control group (tPA + sham TUS)
Control group (tPA + sham TUS) During the primary phase of the study, subjects will be randomized 1:1
Device: tPA in combination with the Sonolysis Headframe (Sham TUS)
tPA per approved labeling Sham (inactive) TUS insonation via the Sonolysis Headframe: minimum 90 minutes - maximum 120 minutes
Other Name: Aureva Headframe (Sham TUS) with Tissue Plaminogen Activator (tPA)
Active Comparator: Treatment group (tPA + TUS)
Treatment group (tPA + TUS): Lead-in phase and Primary phase
Device: tPA in combination with the Sonolysis Headframe (TUS)
tPA: 60 minutes per approved labeling TUS insonation via the Sonolysis Headframe: minimum 90 minutes - maximum 120 minutes
Other Name: Aureva Headframe (TUS) with Tissue Plaminogen Activator (tPA)
- Complete recanalization measured by modified Arterial Occlusive Lesion (mAOL) [ Time Frame: 90-120 minutes post TUS treatment before EVT ]Complete recanalization of the primary occluded vessel as measured by the modified Arterial Occlusive Lesion (mAOL) scoring system. The mAOL assigns a score from 0 to 3, which represents the range from no recanalization to complete recanalization based on either the presence (grade 2 or 3) or absence (grades 0 or 1) of any downstream flow.
- modified Rankin Scale (mRS) score 0-2 [ Time Frame: 90 days +/- 10 days ]Functional dependence at 90 days as measured by the modified Rankin Scale (mRS). The mRS consists of 7 grades, (0-6), with 0 corresponding to no symptoms and 6 corresponding to death. For this study, functional independence will be defined as those subjects that achieve a mRS score of 0-2 at 90 days.
- Neurologic Status at 24 hours post treatment measured by National Institute of Health's Stroke Scale (NIHSS). [ Time Frame: 24 hours post TUS treatment ]NIHSS has 15 items. Ratings for each item are scored on a 0-3 to 0-5 scale, with a total score of 0 for normal and 42 for maximally impaired.
- Partial or complete recanalization as measured by mAOL score of 2-3. [ Time Frame: 90-120 minutes post TUS treatment before EVT ]See description in Primary Outcome Measure.
- Partial or complete recanalization as measured by Thrombolysis In Cerebral Ischemia (TICI) score of 2-3 [ Time Frame: 90-120 minutes post TUS treatment before EVT ]TICI Scale:  - No antegrade flow beyond the point of occlusion.  - The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction.  - The contrast material passes beyond the obstruction and opacifies the arterial bed distal to the obstruction. However, the rate of entry of contrast into the vessel distal to the obstruction and/or its rate of clearance from the distal bed are perceptibly slower than its entry into and/or clearance from comparable areas not perfused by the previously occluded vessel.  - Antegrade flow into the bed distal to the obstruction occurs as promptly as into the obstruction and clearance of contrast material from the involved bed is as rapid as from an uninvolved other bed of the same vessel or the opposite cerebral artery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519737
|United States, Tennessee|
|The University of Tennessee Health Science Center|
|Memphis, Tennessee, United States, 38163|
|United States, Texas|
|Memorial Hermann Hospital - Texas Medical Center (TMC)|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Andrei V Alexandrov, MD||University of Tennessee Health Science Center|