Phase 2 Completed N=38 Treatment

CLOTBUST Hands-Free: A Phase I/II Pilot Safety Trial

Source: ClinicalTrials.gov NCT01240356 ↗

Enrolled (actual)

Serious AEs

25.7%

Results posted

May 2016

Primary outcomePrimary: Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain — 0 participants

Summary

The purpose of CLOTBUST-HF is to determine the safety of a novel, external Hands-Free transcranial Doppler (TCD) ultrasound system in healthy volunteers and ischemic stroke patients. If found to be safe, the widespread use of operator-independent, ultrasound-enhanced thrombolysis will allow the planning for a large Phase III efficacy trial.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain	—	—
PRIMARY Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage	—	—
PRIMARY Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination	—	—
SECONDARY Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD	—	—
SECONDARY Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems	40	—
SECONDARY Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale	5	—
SECONDARY Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS)	25	—

Eligibility Criteria

INCLUSION CRITERIA

Phase I Safety (healthy volunteers):

Presence of temporal windows as measured first by an FDA-approved diagnostic TCD device.
Age ≥ 18 years old.
Signed informed consent.

Phase II (0-3 hours ischemic stroke patients):

Disabling focal neurological deficit (NIHSS > 4 points);
No evidence of hemorrhage on non-contrast head CT scan;
Intravenous rt-PA (0.9 mg/kg, 10% bolus 90% infusion over 1 hour, maximum dose 90 mg) infusion initiated within 3 hours of symptom onset;
Diagnostic TCD completed and HF-TCD placed before rt-PA bolus.
Diagnostic TCD confirms intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA) or distal basilar artery.
Age ≥ 18 years old.
Signed informed consent.

Phase II (3-6 hours ischemic stroke patients):

Measurable focal neurological deficit (NIHSS > 4 points);
No evidence of hemorrhage on non-contrast head CT scan;
Diagnostic TCD confirms intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA) or distal basilar artery.
Presence of neuroimaging defined mismatch (CT or MRI prior to enrollment)
CT-perfusion
≥ 20% difference between affected territories on Time to Peak (TTP) and Cerebral Blood Volume (CBV) maps.
MRI Diffusion-Perfusion mismatch
≥ 20% difference between diffusion-weighted imaging (DWI) lesion and territory of perfusion delay perfusion weighted imaging (PWI).
Age ≥ 18 years old.
Signed informed consent.

EXCLUSION CRITERIA

Phase I Safety (healthy volunteers):

History of any neurological disease affecting the central nervous system;
Lack of temporal windows.
History of renal disease or glomerular filtration rate (GFR) 100cc of tissue);
Baseline MRI imaging demonstrating delayed perfusion of > 8 seconds in >100cc of brain parenchyma26;
Patients receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment;
Significant concurrent medical/neurological conditions or deviation from normal laboratory test values at baseline that, in the opinion of the investigator, pose significant risk to the patient and warrant exclusion from the study;
Known severe chronic obstructive pulmonary disease (COPD) (baseline oxygen saturation < 80% on room air);
Known right-to-left cardiac shunt.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01240356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.