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

Completed · Phase 1/Phase 2

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT01240356

Run by

The University of Texas Health Science Center, Houston

People needed

35

Starts

2008-12-01

Expected to finish

2013-10-01

Last updated by the study team

2016-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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) < 60.
• Contraindication to MRI (e.g., pacemaker, spinal cord stimulator, severe claustrophobia)
• Phase II (0-3 hours ischemic stroke patients):
• Absent temporal windows in patients with anterior circulation ischemia;
• Intra-arterial thrombolysis;
• Patient refusal to give informed consent to participate in the CLOTBUST-HF trial;
• Contraindications for intravenous rt-PA (NINDS rt-PA Stroke Study Protocol)2.
• Phase II (3-6 hours ischemic stroke patients):
• Absent temporal windows in patients with anterior circulation ischemia;
• Intra-arterial thrombolysis;
• Patient refusal to give informed consent to participate in the CLOTBUST-HF trial;
• History of allergic response to Definity® microspheres or microbubbles currently being tested (MRX-801);
• Baseline imaging consistent with a malignant ischemic pattern (low CBV values or DWI territory >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.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• UT Medical School-Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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