Clinical trials, devices, unproven treatments, and clinical equipoise

Stroke

Volumn 40, Issue 6, 2009, Pages

  Wasiewski, Warren W ^a,c   Johnston, Karen C ^b  

^a Neurobiological Technologies Inc   (United States)

^b UNIVERSITY OF VIRGINIA   (United States)

^c 2000 Powell St   (United States)

Author keywords

Clinical trials; Devices; Equipose; Stroke treatment

Indexed keywords

ARTICLE; CLINICAL RESEARCH; EVIDENCE BASED MEDICINE; HUMAN; OUTCOME ASSESSMENT; PATIENT SELECTION; PRIORITY JOURNAL; STROKE; APPARATUS, EQUIPMENT AND SUPPLIES; CLINICAL TRIAL; NEUROSURGERY;

FIBRINOLYTIC AGENT; TISSUE PLASMINOGEN ACTIVATOR;

CLINICAL TRIALS AS TOPIC; EQUIPMENT AND SUPPLIES; FIBRINOLYTIC AGENTS; HUMANS; NEUROSURGICAL PROCEDURES; STROKE; TISSUE PLASMINOGEN ACTIVATOR;

EID: 66849084275     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/STROKEAHA.108.531939     Document Type: Article

References (7)

1. 1. Penumbra, Inc (San Leandro, CA). 501(k) Summary Letter: FDA. Sept 20, 2007. Reference No K072718 (Penumbra System).
2. McDougall C, Clark W, Mayer T, Doerfler A, Grunwald I, Berkefeld J, Lopes D, Shownkeen H, Madison M, Budzik R, Heck D, Frei D, Zaidat O, Branca V, Ahktar N, Rai A, Chaloupka J, Hellinger F, Rasmussen P, Rudolph S, Spiegel G. The penumbra stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in acute ischemic stroke. Late-Breaking Science Abstracts presented at the International Stroke Conference; Feb 20-22, 2008; New Orleans, LA.
3. Concentric Medical Inc (Mountain View, CA). 501(k) Summary Letter FDA. Aug 3, 2004. Reference No K033736 (Concentric Merci® Retriever).
4. Smith WS, Sung G, Starkman S, Saver JL, Kidwell CS, Gobin YP, Lutsep HL, Nesbit GM, Grobelny T, Rymer MM, Silverman IE, Higashida RT, Budzik RF. Marks MP for the MERCI Trial Investigators. Safety and efficacy of mechanical embolectomy in acute ischemic stroke: results of the MERCI trial. Stroke 2005;36:1432-1438.
5. Smith WS, Sung G, Saver J, Budzik R, Duckwiler G, Liebeskind DS, Lutsep HL, Rymer MM, Higashida RT, Starkman S, Gobin YP; for the Multi MERCI Investigators. Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke 2008;39:1205-1212.
6. Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. NEnglJMed. 1995;333:1581-1587.
7. Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F; for the PROACT Investigators. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. JAMA. 1999;282:2003-2011.