Aureva Transcranial Ultrasound Device With tPA in Patients With Acute Ischemic Stroke

NCT03519737 | Unknown DMC FDA Device

• 1 other identifier: CM-CP-01
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, placebo controlled, double-blind phase 3 clinical study to evaluate the efficacy and safety of transcranial ultrasound (TUS) using the Sonolysis Headframe as an adjunctive therapy to intravenous (IV) tissue plasminogen activator (tPA) therapy in subjects with acute ischemic stroke that initially present at non-endovascular (EVT) treating hospitals that have established transport services in place to transfer subjects to hospitals capable of performing EVT.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Acute Stroke

Outcome Measures

Primary Outcomes (1)

• Complete recanalization measured by modified Arterial Occlusive Lesion (mAOL)

  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.

  90-120 minutes post TUS treatment before EVT

Secondary Outcomes (4)

• modified Rankin Scale (mRS) score 0-2

  90 days +/- 10 days

• Neurologic Status at 24 hours post treatment measured by National Institute of Health's Stroke Scale (NIHSS).

  24 hours post TUS treatment

• Partial or complete recanalization as measured by mAOL score of 2-3.

  90-120 minutes post TUS treatment before EVT

• Partial or complete recanalization as measured by Thrombolysis In Cerebral Ischemia (TICI) score of 2-3

  90-120 minutes post TUS treatment before EVT

Study Arms (2)

Control group (tPA + sham TUS)

SHAM COMPARATOR

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)

Treatment group (tPA + TUS)

ACTIVE COMPARATOR

Treatment group (tPA + TUS): Lead-in phase and Primary phase

Device: tPA in combination with the Sonolysis Headframe (TUS)

Interventions

tPA in combination with the Sonolysis Headframe (TUS) DEVICE

tPA: 60 minutes per approved labeling TUS insonation via the Sonolysis Headframe: minimum 90 minutes - maximum 120 minutes

Also known as: Aureva Headframe (TUS) with Tissue Plaminogen Activator (tPA)

Treatment group (tPA + TUS)

tPA in combination with the Sonolysis Headframe (Sham TUS) DEVICE

tPA per approved labeling Sham (inactive) TUS insonation via the Sonolysis Headframe: minimum 90 minutes - maximum 120 minutes

Also known as: Aureva Headframe (Sham TUS) with Tissue Plaminogen Activator (tPA)

Control group (tPA + sham TUS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with acute ischemic stroke
• Subjects that initially present at non-EVT treating hospitals that have established transport services in place to transfer subjects to hospitals capable of performing EVT
• Males or females 18 - 80 years of age
• Subjects presenting within time window for IV tPA treatment approved by local regulatory authorities but no more than 4.5 hours from onset of symptoms
• No signs of intracranial bleeding on assessment by non-contrast CT
• Subjects that in the opinion of the treating physician require treatment with full dose of IV tPA (0.9mg/kg) as standard of care per institutional standards
• SBP ≤ 185 mmHg and DBP ≤ 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus
• Pre-morbid mRS of 0-1
• Arterial occlusion in the middle cerebral artery (MCA) M1 or proximal M2, intracranial carotid T, anterior cerebral artery (ACA) A1, basilar, proximal posterior cerebral artery (PCA) P1 or intracranial tandem lesions in these locations visible on CT angiography (CTA)
• Provision of informed consent as demonstrated by the subject's signature or by the signature of the subject's authorized legal representative on the Informed Consent Form in accordance with all local and national regulations and no later than 15 minutes after standard of care tPA administration

You may not qualify if:

• Tandem lesions where one lesion is extracranial (carotid or vertebral artery)
• ASPECTS score \< 6 on non contrast CT or ischemic changes that in the opinion of the investigator would be medically inappropriate for reperfusion therapy
• Poor collateral circulation defined as minimal or no pial collaterals in \>50% of the ischemic territory
• Expected time between activation of Sonolysis Headframe and initiation of EVT \< 90 minutes
• Impaired renal function defined as eGFR \< 60 mL/min/1.73 m2
• No permanent address or phone number
• Any investigational drug \<14 days prior to study participation
• Subjects with known allergy to x-ray contrast material
• Subjects with any standard contraindication for intravenous tPA therapy as per local or national guidelines

Sponsors & Collaborators

• Cerevast Medical, Inc.: lead

Study Sites (2)

The University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Memorial Hermann Hospital - Texas Medical Center (TMC)

Houston, Texas, 77030, United States

Location

Related Publications (25)

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MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrei V Alexandrov, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sham control and active insonation. During lead-in phase for the first 40 subjects, only active insonation will be programmed.

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 9, 2018
• Study Start: August 17, 2018
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)