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

Stroke

Volumn 44, Issue 12, 2013, Pages 3376-3381

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

^a UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

^b Center for Clinical and Translational Sciences   (United States)

^c UNIVERSITY OF TEXAS   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^e UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

Author keywords

CLOTBUST; Doppler; Operator independent device; Reperfusion; Sonothrombolysis; Stroke; Thrombolytic therapy; Transcranial; Ultrasonography

Indexed keywords

ALTEPLASE;

ADULT; ARTICLE; BACTERIAL ENDOCARDITIS; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CLINICAL ARTICLE; COMPUTED TOMOGRAPHIC ANGIOGRAPHY; CONTROLLED STUDY; DOPPLER ECHOGRAPHY; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; INTERNAL CAROTID ARTERY; INTERNAL CAROTID ARTERY OCCLUSION; MALE; MIDDLE CEREBRAL ARTERY OCCLUSION; MULTICENTER STUDY; NATIONAL HEALTH ORGANIZATION; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NEUROIMAGING; OCCLUSIVE CEREBROVASCULAR DISEASE; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PILOT STUDY; PREDICTIVE VALUE; PRIORITY JOURNAL; PULSE WAVE; RANKIN SCALE; RECANALIZATION; STROKE PATIENT; SYMPTOM; TRANSCRANIAL DOPPLER; VERTEBRAL ARTERY STENOSIS;

CLOTBUST; OPERATOR-INDEPENDENT DEVICE; REPERFUSION; SONOTHROMBOLYSIS; STROKE; THROMBOLYTIC THERAPY; ULTRASONOGRAPHY, DOPPLER, TRANSCRANIAL;

AGED; AGED, 80 AND OVER; BRAIN ISCHEMIA; COMBINED MODALITY THERAPY; FEMALE; FIBRINOLYTIC AGENTS; HUMANS; MALE; MIDDLE AGED; PILOT PROJECTS; PROSPECTIVE STUDIES; STROKE; THROMBOLYTIC THERAPY; TISSUE PLASMINOGEN ACTIVATOR; TREATMENT OUTCOME; ULTRASONOGRAPHY, DOPPLER, TRANSCRANIAL;

EID: 84889264148     PISSN: 00392499     EISSN: 15244628     Source Type: Journal    
DOI: 10.1161/STROKEAHA.113.002713     Document Type: Article

References (22)

1. Alexandrov AV, Burgin WS, Demchuk AM, El-Mitwalli A, Grotta JC. Speed of intracranial clot lysis with intravenous tissue plasminogen activator therapy: sonographic classification and short-term improvement. Circulation. 2001;103:2897-2902.
2. Demchuk AM, Burgin WS, Christou I, Felberg RA, Barber PA, Hill MD, et al. Thrombolysis in brain ischemia (TIBI) transcranial Doppler flow grades predict clinical severity, early recovery, and mortality in patients treated with intravenous tissue plasminogen activator. Stroke. 2001;32:89-93.
3. Labiche LA, Al-Senani F, Wojner AW, Grotta JC, Malkoff M, Alexandrov AV. Is the benefit of early recanalization sustained at 3 months? A prospective cohort study. Stroke. 2003;34:695-698.
4. Alexandrov AV, Demchuk AM, Burgin WS, Robinson DJ, Grotta JC; CLOTBUST Investigators. Ultrasound-enhanced thrombolysis for acute ischemic stroke: phase I. Findings of the CLOTBUST trial. J Neuroimaging. 2004;14:113-117.
5. Alexandrov AV, Grotta JC. Arterial reocclusion in stroke patients treated with intravenous tissue plasminogen activator. Neurology. 2002;59:862-867.
6. Barreto AD, Alexandrov AV. Adjunctive and alternative approaches to current reperfusion therapy. Stroke. 2012;43:591-598.
7. Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, et al. Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke. New Engl J Med. 2004;351:2170-2178.
8. Ricci S, Dinia L, Del Sette M, Anzola P, Mazzoli T, Cenciarelli S, et al. Sonothrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2012;10:CD008348.
9. Saqqur M, Tsivgoulis G, Nicoli F, Skoloudik D, Sharma VK, Larrue V, et al. The role of sonolysis and sonothrombolysis in acute ischemic stroke: a systematic review and meta-analysis of randomized controlled trials and case-control studies. J Neuroimaging. 2013. http://onlinelibrary.wiley.com/ journal/10.1111/(ISSN)1552-6569/earlyview. Accessed August 23, 2013.
10. Tsivgoulis G, Eggers J, Ribo M, Perren F, Saqqur M, Rubiera M, et al. Safety and efficacy of ultrasound-enhanced thrombolysis: a comprehensive review and meta-analysis of randomized and nonrandomized studies. Stroke. 2010;41:280-287.
11. Barlinn K, Barreto AD, Sisson A, Liebeskind DS, Schafer ME, Alleman J, et al. Clotbust-hands free: initial safety testing of a novel operatorindependent ultrasound device in stroke-free volunteers. Stroke. 2013;44:1641-1646.
12. Alexandrov AV, Sloan MA, Tegeler CH, Newell DN, Lumsden A, Garami Z, et al. Practice standards for transcranial Doppler (TCD) ultrasound. Part II. Clinical indications and expected outcomes. J Neuroimaging. 2012;22:215-224.
13. Tsivgoulis G, Ribo M, Rubiera M, Vasdekis SN, Barlinn K, Athanasiadis D, et al. Real-time validation of transcranial Doppler criteria in assessing recanalization during intra-arterial procedures for acute ischemic stroke: an international, multicenter study. Stroke. 2013;44:394-400.
14. Tsivgoulis G, Sharma VK, Lao AY, Malkoff MD, Alexandrov AV. Validation of transcranial Doppler with computed tomography angiography in acute cerebral ischemia. Stroke. 2007;38:1245-1249.
15. Tsivgoulis G, Alexandrov AV. Ultrasound-enhanced thrombolysis in acute ischemic stroke: potential, failures, and safety. Neurotherapeutics. 2007;4:420-427.
16. Meairs S, Alonso A, Hennerici MG. Progress in sonothrombolysis for the treatment of stroke. Stroke. 2012;43:1706-1710.
17. Alexandrov AV, Mikulik R, Ribo M, Sharma VK, Lao AY, Tsivgoulis G, et al. A pilot randomized clinical safety study of sonothrombolysis augmentation with ultrasound-activated perflutren-lipid microspheres for acute ischemic stroke. Stroke. 2008;39:1464-1469.
18. Molina CA, Barreto AD, Tsivgoulis G, Sierzenski P, Malkoff MD, Rubiera M, et al. Transcranial ultrasound in clinical sonothrombolysis (TUCSON) trial. Ann Neurol. 2009;66:28-38.
19. Molina CA, Ribo M, Rubiera M, Montaner J, Santamarina E, Delgado-Mederos R, et al. Microbubble administration accelerates clot lysis during continuous 2-MHz ultrasound monitoring in stroke patients treated with intravenous tissue plasminogen activator. Stroke. 2006;37:425-429.
20. Saqqur M, Uchino K, Demchuk AM, Molina CA, Garami Z, Calleja S, et al. Site of arterial occlusion identified by transcranial Doppler predicts the response to intravenous thrombolysis for stroke. Stroke. 2007;38:948-954.
21. Saver JL, Fonarow GC, Smith EE, Reeves MJ, Grau-Sepulveda MV, Pan W, et al. Time to treatment with intravenous tissue plasminogen activator and outcome from acute ischemic stroke. J Am Med Assoc. 2013;309:2480-2488.
22. Smith WS, Lev MH, English JD, Camargo EC, Chou M, Johnston SC, et al. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009;40:3834-3840.