Clotbust-hands free

Pilot safety study of a novel operator-independent ultrasound device in patients with acute ischemic stroke

Andrew D. Barreto, Andrei Alexandrov, Loren Shen, April Sisson, Andrew W. Bursaw, Preeti Sahota, Hui Peng, Manouchehr Ardjomand-Hessabi, Renganayaki Pandurengan, Mohammad H. Rahbar, Kristian Barlinn, Hari Indupuru, Nicole R. Gonzales, Sean I. Savitz, James C. Grotta

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

BACKGROUND AND PURPOSE - The Combined Lysis of Thrombus in Brain Ischemia With Transcranial Ultrasound and Systemic T-PA-Hands-Free (CLOTBUST-HF) study is a first-in-human, National Institutes of Health-sponsored, multicenter, open-label, pilot safety trial of tissue-type plasminogen activator (tPA) plus a novel operator-independent ultrasound device in patients with ischemic stroke caused by proximal intracranial occlusion. METHODS - All patients received standard-dose intravenous tPA, and shortly after tPA bolus, the CLOTBUST-HF device delivered 2-hour therapeutic exposure to 2-MHz pulsed-wave ultrasound. Primary outcome was occurrence of symptomatic intracerebral hemorrhage. All patients underwent pretreatment and post-treatment transcranial Doppler ultrasound or CT angiography. National Institutes of Health Stroke Scale scores were collected at 2 hours and modified Rankin scale at 90 days. RESULTS - Summary characteristics of all 20 enrolled patients were 60% men, mean age of 63 (SD=14) years, and median National Institutes of Health Stroke Scale of 15. Sites of pretreatment occlusion were as follows: 14 of 20 (70%) middle cerebral artery, 3 of 20 (15%) terminal internal carotid artery, and 3 of 20 (15%) vertebral artery. The median (interquartile range) time to tPA at the beginning of sonothrombolysis was 22 (13.5-29.0) minutes. All patients tolerated the entire 2 hours of insonation, and none developed symptomatic intracerebral hemorrhage. No serious adverse events were related to the study device. Rates of 2-hour recanalization were as follows: 8 of 20 (40%; 95% confidence interval, 19%-64%) complete and 2 of 20 (10%; 95% confidence interval, 1%-32%) partial. Middle cerebral artery occlusions demonstrated the greatest complete recanalization rate: 8 of 14 (57%; 95% confidence interval, 29%-82%). At 90 days, 5 of 20 (25%, 95% confidence interval, 7%-49) patients had a modified Rankin scale of 0 to 1. CONCLUSIONS - Sonothrombolysis using a novel, operator-independent device, in combination with systemic tPA, seems safe, and recanalization rates warrant evaluation in a phase III efficacy trial. CLINICAL TRIAL REGISTRATION - : URL: http://www.clinicaltrials.gov. Unique identifier: CLOTBUST-HF NCT01240356.

Original languageEnglish (US)
Pages (from-to)3376-3381
Number of pages6
JournalStroke
Volume44
Issue number12
DOIs
StatePublished - Dec 1 2013

Fingerprint

Hand
Plasminogen Activators
Stroke
Safety
Equipment and Supplies
National Institutes of Health (U.S.)
Brain Ischemia
Confidence Intervals
Thrombosis
Cerebral Hemorrhage
Doppler Ultrasonography
Vertebral Artery
Middle Cerebral Artery Infarction
Middle Cerebral Artery
Internal Carotid Artery
Tissue Plasminogen Activator
Clinical Trials
Therapeutics

All Science Journal Classification (ASJC) codes

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

Clotbust-hands free : Pilot safety study of a novel operator-independent ultrasound device in patients with acute ischemic stroke. / Barreto, Andrew D.; Alexandrov, Andrei; Shen, Loren; Sisson, April; Bursaw, Andrew W.; Sahota, Preeti; Peng, Hui; Ardjomand-Hessabi, Manouchehr; Pandurengan, Renganayaki; Rahbar, Mohammad H.; Barlinn, Kristian; Indupuru, Hari; Gonzales, Nicole R.; Savitz, Sean I.; Grotta, James C.

In: Stroke, Vol. 44, No. 12, 01.12.2013, p. 3376-3381.

Research output: Contribution to journalArticle

Barreto, AD, Alexandrov, A, Shen, L, Sisson, A, Bursaw, AW, Sahota, P, Peng, H, Ardjomand-Hessabi, M, Pandurengan, R, Rahbar, MH, Barlinn, K, Indupuru, H, Gonzales, NR, Savitz, SI & Grotta, JC 2013, 'Clotbust-hands free: Pilot safety study of a novel operator-independent ultrasound device in patients with acute ischemic stroke', Stroke, vol. 44, no. 12, pp. 3376-3381. https://doi.org/10.1161/STROKEAHA.113.002713
Barreto, Andrew D. ; Alexandrov, Andrei ; Shen, Loren ; Sisson, April ; Bursaw, Andrew W. ; Sahota, Preeti ; Peng, Hui ; Ardjomand-Hessabi, Manouchehr ; Pandurengan, Renganayaki ; Rahbar, Mohammad H. ; Barlinn, Kristian ; Indupuru, Hari ; Gonzales, Nicole R. ; Savitz, Sean I. ; Grotta, James C. / Clotbust-hands free : Pilot safety study of a novel operator-independent ultrasound device in patients with acute ischemic stroke. In: Stroke. 2013 ; Vol. 44, No. 12. pp. 3376-3381.
@article{6af64e6e195e474c831c4d72877c158e,
title = "Clotbust-hands free: Pilot safety study of a novel operator-independent ultrasound device in patients with acute ischemic stroke",
abstract = "BACKGROUND AND PURPOSE - The Combined Lysis of Thrombus in Brain Ischemia With Transcranial Ultrasound and Systemic T-PA-Hands-Free (CLOTBUST-HF) study is a first-in-human, National Institutes of Health-sponsored, multicenter, open-label, pilot safety trial of tissue-type plasminogen activator (tPA) plus a novel operator-independent ultrasound device in patients with ischemic stroke caused by proximal intracranial occlusion. METHODS - All patients received standard-dose intravenous tPA, and shortly after tPA bolus, the CLOTBUST-HF device delivered 2-hour therapeutic exposure to 2-MHz pulsed-wave ultrasound. Primary outcome was occurrence of symptomatic intracerebral hemorrhage. All patients underwent pretreatment and post-treatment transcranial Doppler ultrasound or CT angiography. National Institutes of Health Stroke Scale scores were collected at 2 hours and modified Rankin scale at 90 days. RESULTS - Summary characteristics of all 20 enrolled patients were 60{\%} men, mean age of 63 (SD=14) years, and median National Institutes of Health Stroke Scale of 15. Sites of pretreatment occlusion were as follows: 14 of 20 (70{\%}) middle cerebral artery, 3 of 20 (15{\%}) terminal internal carotid artery, and 3 of 20 (15{\%}) vertebral artery. The median (interquartile range) time to tPA at the beginning of sonothrombolysis was 22 (13.5-29.0) minutes. All patients tolerated the entire 2 hours of insonation, and none developed symptomatic intracerebral hemorrhage. No serious adverse events were related to the study device. Rates of 2-hour recanalization were as follows: 8 of 20 (40{\%}; 95{\%} confidence interval, 19{\%}-64{\%}) complete and 2 of 20 (10{\%}; 95{\%} confidence interval, 1{\%}-32{\%}) partial. Middle cerebral artery occlusions demonstrated the greatest complete recanalization rate: 8 of 14 (57{\%}; 95{\%} confidence interval, 29{\%}-82{\%}). At 90 days, 5 of 20 (25{\%}, 95{\%} confidence interval, 7{\%}-49) patients had a modified Rankin scale of 0 to 1. CONCLUSIONS - Sonothrombolysis using a novel, operator-independent device, in combination with systemic tPA, seems safe, and recanalization rates warrant evaluation in a phase III efficacy trial. CLINICAL TRIAL REGISTRATION - : URL: http://www.clinicaltrials.gov. Unique identifier: CLOTBUST-HF NCT01240356.",
author = "Barreto, {Andrew D.} and Andrei Alexandrov and Loren Shen and April Sisson and Bursaw, {Andrew W.} and Preeti Sahota and Hui Peng and Manouchehr Ardjomand-Hessabi and Renganayaki Pandurengan and Rahbar, {Mohammad H.} and Kristian Barlinn and Hari Indupuru and Gonzales, {Nicole R.} and Savitz, {Sean I.} and Grotta, {James C.}",
year = "2013",
month = "12",
day = "1",
doi = "10.1161/STROKEAHA.113.002713",
language = "English (US)",
volume = "44",
pages = "3376--3381",
journal = "Stroke",
issn = "0039-2499",
publisher = "Lippincott Williams and Wilkins",
number = "12",

}

TY - JOUR

T1 - Clotbust-hands free

T2 - Pilot safety study of a novel operator-independent ultrasound device in patients with acute ischemic stroke

AU - Barreto, Andrew D.

AU - Alexandrov, Andrei

AU - Shen, Loren

AU - Sisson, April

AU - Bursaw, Andrew W.

AU - Sahota, Preeti

AU - Peng, Hui

AU - Ardjomand-Hessabi, Manouchehr

AU - Pandurengan, Renganayaki

AU - Rahbar, Mohammad H.

AU - Barlinn, Kristian

AU - Indupuru, Hari

AU - Gonzales, Nicole R.

AU - Savitz, Sean I.

AU - Grotta, James C.

PY - 2013/12/1

Y1 - 2013/12/1

N2 - BACKGROUND AND PURPOSE - The Combined Lysis of Thrombus in Brain Ischemia With Transcranial Ultrasound and Systemic T-PA-Hands-Free (CLOTBUST-HF) study is a first-in-human, National Institutes of Health-sponsored, multicenter, open-label, pilot safety trial of tissue-type plasminogen activator (tPA) plus a novel operator-independent ultrasound device in patients with ischemic stroke caused by proximal intracranial occlusion. METHODS - All patients received standard-dose intravenous tPA, and shortly after tPA bolus, the CLOTBUST-HF device delivered 2-hour therapeutic exposure to 2-MHz pulsed-wave ultrasound. Primary outcome was occurrence of symptomatic intracerebral hemorrhage. All patients underwent pretreatment and post-treatment transcranial Doppler ultrasound or CT angiography. National Institutes of Health Stroke Scale scores were collected at 2 hours and modified Rankin scale at 90 days. RESULTS - Summary characteristics of all 20 enrolled patients were 60% men, mean age of 63 (SD=14) years, and median National Institutes of Health Stroke Scale of 15. Sites of pretreatment occlusion were as follows: 14 of 20 (70%) middle cerebral artery, 3 of 20 (15%) terminal internal carotid artery, and 3 of 20 (15%) vertebral artery. The median (interquartile range) time to tPA at the beginning of sonothrombolysis was 22 (13.5-29.0) minutes. All patients tolerated the entire 2 hours of insonation, and none developed symptomatic intracerebral hemorrhage. No serious adverse events were related to the study device. Rates of 2-hour recanalization were as follows: 8 of 20 (40%; 95% confidence interval, 19%-64%) complete and 2 of 20 (10%; 95% confidence interval, 1%-32%) partial. Middle cerebral artery occlusions demonstrated the greatest complete recanalization rate: 8 of 14 (57%; 95% confidence interval, 29%-82%). At 90 days, 5 of 20 (25%, 95% confidence interval, 7%-49) patients had a modified Rankin scale of 0 to 1. CONCLUSIONS - Sonothrombolysis using a novel, operator-independent device, in combination with systemic tPA, seems safe, and recanalization rates warrant evaluation in a phase III efficacy trial. CLINICAL TRIAL REGISTRATION - : URL: http://www.clinicaltrials.gov. Unique identifier: CLOTBUST-HF NCT01240356.

AB - BACKGROUND AND PURPOSE - The Combined Lysis of Thrombus in Brain Ischemia With Transcranial Ultrasound and Systemic T-PA-Hands-Free (CLOTBUST-HF) study is a first-in-human, National Institutes of Health-sponsored, multicenter, open-label, pilot safety trial of tissue-type plasminogen activator (tPA) plus a novel operator-independent ultrasound device in patients with ischemic stroke caused by proximal intracranial occlusion. METHODS - All patients received standard-dose intravenous tPA, and shortly after tPA bolus, the CLOTBUST-HF device delivered 2-hour therapeutic exposure to 2-MHz pulsed-wave ultrasound. Primary outcome was occurrence of symptomatic intracerebral hemorrhage. All patients underwent pretreatment and post-treatment transcranial Doppler ultrasound or CT angiography. National Institutes of Health Stroke Scale scores were collected at 2 hours and modified Rankin scale at 90 days. RESULTS - Summary characteristics of all 20 enrolled patients were 60% men, mean age of 63 (SD=14) years, and median National Institutes of Health Stroke Scale of 15. Sites of pretreatment occlusion were as follows: 14 of 20 (70%) middle cerebral artery, 3 of 20 (15%) terminal internal carotid artery, and 3 of 20 (15%) vertebral artery. The median (interquartile range) time to tPA at the beginning of sonothrombolysis was 22 (13.5-29.0) minutes. All patients tolerated the entire 2 hours of insonation, and none developed symptomatic intracerebral hemorrhage. No serious adverse events were related to the study device. Rates of 2-hour recanalization were as follows: 8 of 20 (40%; 95% confidence interval, 19%-64%) complete and 2 of 20 (10%; 95% confidence interval, 1%-32%) partial. Middle cerebral artery occlusions demonstrated the greatest complete recanalization rate: 8 of 14 (57%; 95% confidence interval, 29%-82%). At 90 days, 5 of 20 (25%, 95% confidence interval, 7%-49) patients had a modified Rankin scale of 0 to 1. CONCLUSIONS - Sonothrombolysis using a novel, operator-independent device, in combination with systemic tPA, seems safe, and recanalization rates warrant evaluation in a phase III efficacy trial. CLINICAL TRIAL REGISTRATION - : URL: http://www.clinicaltrials.gov. Unique identifier: CLOTBUST-HF NCT01240356.

UR - http://www.scopus.com/inward/record.url?scp=84889264148&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84889264148&partnerID=8YFLogxK

U2 - 10.1161/STROKEAHA.113.002713

DO - 10.1161/STROKEAHA.113.002713

M3 - Article

VL - 44

SP - 3376

EP - 3381

JO - Stroke

JF - Stroke

SN - 0039-2499

IS - 12

ER -