Major Ongoing Stroke Trials
2007; Lippincott Williams & Wilkins; Volume: 38; Issue: 6 Linguagem: Inglês
10.1161/01.str.0000271360.99976.15
ISSN1524-4628
Tópico(s)Aortic Thrombus and Embolism
ResumoHomeStrokeVol. 38, No. 6Major Ongoing Stroke Trials Free AccessOtherPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessOtherPDF/EPUBMajor Ongoing Stroke Trials Originally published1 Jun 2007https://doi.org/10.1161/01.STR.0000271360.99976.15Stroke. 2007;38:e39–e47The following is a list of major ongoing studies about stroke. Information about other multicenter studies that might be included in this list should be submitted to the Stroke Editorial Office by the Principal Investigator. The list will appear online in the February, June and October issues of Stroke.Aortic Arch Related Cerebral Hazard (ARCH)This study is designed to compare the efficacy of warfarin (target INR 2.0 to 3.0) with that of aspirin (75 to 150 mg per day) in combination with clopidogrel (75 mg per day) in the secondary prevention of vascular events in patients with stroke or systemic arterial embolism who are found to have significant atheroma of the aortic arch. Patients will be followed by 4 monthly reviews from randomization to the end of the study. The primary end point is time to one of a composite of recurrent ischemic stroke, intracranial hemorrhage, myocardial infarction, peripheral embolism or vascular death.Steering Committee: P. Amarenco, G.A. Donnan, S.M. Davis, B.R. Chambers, A. Cohen, G.J. Hankey, E. Jones, C.R. Levi and P. Ravaud.Contact: Australia: Prof Geoffrey Donnan, Coordination Centre, NSRI, Level 1, Neurosciences Building, Austin Health, 300 Waterdale Road, Heidelberg Heights, Vic 3081, Australia. Phone 61-3-9496-2699. Fax 61-3-9457-2650. E-mail [email protected] Europe: Prof Pierre Amarenco, Department of Neurology and Stroke Centre, Bichat - Claude Bernard University Hospital and Medical School Denis Diderot University - Paris VII 46 rue Henri Huchard, 75018 Paris, France. Phone 33-1-40258726 Fax 33-1-4025-7198. E-mail [email protected]Location: Australia: Coordination Centre, National Stroke Research Centre, Austin Health, Heidelberg Heights Vic 3081, Australia.Europe: Coordination Centre, Department of Neurology and Stroke Centre, Bichat- Claude Bernard University Hospital and Medical School Denis Diderot University - Paris VII, 75018 Paris, France.Number of Centers: Australia: 20; Europe: 40Sponsors: The National Health and Medical Research Council of Australia; The National Heart Foundation; The Medical Research Council of France; and the Sanofi-Aventis Company.Dates of Study: Oct 2002 to Dec 2008*Asymptomatic Carotid Emboli Study (ACES)Better ways are required to identify high risk patients with asymptomatic carotid stenosis who may be suitable for endarterectomy. Previous small studies have suggested that the presence of asymptomatic embolic signals detected using transcranial Doppler ultrasound may identify a high risk group. ACES is a large multicentre international prospective study which will determine whether asymptomatic emboli detected in the middle cerebral artery are an independent predictor of stroke and TIA risk in patients with asymptomatic carotid stenosis (≥70%). Carotid stenosis is identified by duplex ultrasound. Unilateral middle cerebral artery transcranial Doppler recordings are made for one hour on each of two occasions at study entry. Recordings are made onto digital audiotape and are analysed by the coordinating centre, blinded to subject identity. Subjects are then followed for two years, at six monthly intervals with repeat 1 hour Doppler recordings at 6, 12, and 18 months and repeat carotid duplex at 12 months. There is also an option to perform cerebrovascular reactivity measurements at study entry. Recruitment began in 2000. 455 patients are currently enrolled in the study and we aim to recruit a total of 480 patients. Recruitment is planned to finish in 2007, with follow-up complete in 2009.Principal Investigator: Hugh Markus, FRCPContact: Sheila Reihill, ACES Study Coordinator, Centre for Clinical Neuroscience, St. George’s University London, SW17 ORE, Phone 020 8725 5374, Fax 020 8725 2950, E-mail [email protected]Location: Austria, China, Croatia, France, Georgia, Germany, Hong-Kong, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Singapore, Slovenia, Spain, United Kingdom, United StatesNumber of Centers: 29 (still recruiting)Sponsor: British Heart FoundationDates of Study: 2000–2008Asymptomatic Carotid Surgery Trial (ACST)This is an international, multicenter trial to assess the place of carotid endarterectomy (CEA) in the management of patients with severe carotid stenosis that are currently asymptomatic. Patients were randomized either to best medical treatment (BMT) alone or to BMT plus CEA. Recruitment is now complete, and 5-year results were published in The Lancet in May 2004, but follow-up continues.Principal Investigators: A.W. Halliday, FRCS; A.O. Mansfield, FRCS; and D.J. Thomas, MD, FRCPContact: Steven Robertson, Trial Manager. Phone +44(0) 20 8725-3746. Fax +44(0)20 8725-3782. E-mail [email protected]Location: The ACST Office, Department of Cardiac and Vascular Sciences, St. Georges University of London, Cranmer Terrace, London SW17 0RE.Number of Centers: 120+Sponsor: Stroke Association and Medical Research Council (UK)Dates of Study: Commenced April 1993 (follow-up ongoing for publication of 10-year results in 2007/2008, but recruitment closed in 2003)Blood Pressure in Acute Stroke Collaboration (BASC)Hypertension and hypotension in the acute phase of stroke are associated with a poor outcome; paradoxically, lowering blood pressure may also worsen outcome. BASC is performing a systematic review of blood pressure change versus outcome in acute stroke trials that involve vasoactive agents. Both group and individual patient data are being analyzed to assess whether therapeutic alteration of blood pressure is safe and effective in improving outcome, and if so, with which agent. Authors of such trials who are willing to share their trial data are invited to contact the investigators.Principal Investigator: Philip Bath, FRCPContact: P.M.W. Bath, FRCP; Division of Stroke Medicine, University of Nottingham, City Hospital Campus, Nottingham NG5 1PB, UK. Phone 44-115-823-1768. Fax 44-115-823-1767. E-mail [email protected]Location: University of Nottingham, Nottingham, UKNumber of Centers: Those centers that have organized a randomized controlled trial in acute stroke involving a vasoactive drug which lowers or raises blood pressure.Sponsor: South Thames & Trent Regional Health Authority National Health Service Research and Development Executives; The Stroke Association. The study is being performed under the auspices of the Cochrane Collaboration Stroke Group and is published in the Cochrane LibraryDates of Study: November 1995 (continuing)Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS)CAVATAS is a randomized, multicenter trial to determine the benefits and risks of percutaneous transluminal angioplasty of the carotid and/or vertebral arteries in patients with symptomatic and asymptomatic cerebrovascular disease. The study includes a randomized comparison between carotid angioplasty and carotid endarterectomy.Principal Investigator: Martin M. Brown, MDContact: Martin M. Brown, MD, FRCP, Professor of Stroke Medicine, Institute of Neurology, Box 6, The National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG, UK. Phone 44-20-7829-8753. Fax 44-20-7833-8613Location: Europe, North America, and AustraliaNumber of Centers: 24. Total number of patients recruited=562.Sponsor: British Heart Foundation, National Health Service Research and Development Programme, The Stroke AssociationDates of Study: April 1992 (continuing). Recruitment stopped on July 31, 1997. Follow-up continues.Web Address: www.cavatas.comCarotid Occlusion Surgery Study (COSS)COSS is a randomized, partially blinded, controlled trial to test whether extracranial-intracranial arterial bypass surgery, when added to best medical therapy, can reduce by 40% subsequent ipsilateral ischemic stroke at 2 years in subjects with recently symptomatic internal carotid artery occlusion and ipsilateral increased oxygen extraction fraction measured by PET. PET scans will be performed within 120 days of the qualifying TIA or stroke on 930 clinically eligible subjects to identify 372 with increased oxygen extraction fraction distal to an occluded carotid who will be randomized to receive surgery or no surgery. Study participants will be followed for 2 years. Follow-up includes clinic visits at 1 month, 3 months and every 3 months thereafter. All participants will receive best medical management, which includes management of hypertension and other medical risk factors.Principal Investigators: William J. Powers, MD (Clinical Coordinating Center), William R. Clarke, PhD (Data Management Center)Contact: Carol Hess, RN, Carotid Occlusion Surgery Study, Box 8111, Washington University School of Medicine, 660 South Euclid Avenue, St. Louis, MO 63110 Phone 314-362-4299. Fax 314-362-4521. E-mail [email protected] Website: www.cosstrial.orgLocation: Washington University School of Medicine, St. Louis, MO (Clinical Coordinating Center) University of Iowa, Iowa City, IA (Data Management Center)Number of Centers: 20 to 40Sponsor: National Institute of Neurological Disorders and Stroke, National Institutes of HealthDates of Study: July 2002–July 2008*Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)CREST is a prospective, randomized, multicenter, clinical trial to assess the relative efficacy of carotid endarterectomy (CEA) versus carotid artery stenting (CAS) using the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection Device in preventing stroke, myocardial infarction and death during the 30-day peri-procedural period and ipsilateral stroke thereafter in subjects with symptomatic and asymptomatic extracranial carotid stenosis. The study includes a lead-in phase for credentialing of interventionalists, beyond their initial training and certification requirements. Approximately 2500 subjects with transient ischemic attack, amaurosis fugax, or nondisabling stroke within 180 days of randomization and ipsilateral carotid stenosis ≥50% (defined as ≥70% by ultrasound or ≥50% by angiography) for symptomatic patients and >60% (defined as >70% by ultrasound or >60% by angiography) for asymptomatic patients will be followed for up to 4 years. Follow-up includes clinic visits at 1, 6, and 12 months, then every 6 months for study duration with phone contact every 3 months. All patients will receive best medical management, which includes treatment with aspirin, management of hypertension and medical risk factors. Recruitment of patients began in December 2000, but the start-up date will vary across centers depending upon their completion of certification and regulatory requirements. Currently 1536 lead-in participants and 1726 randomized subjects have been enrolled. CREST is approved for renewal and continuation from 2007 through 2011.Principal Investigator: Robert W. Hobson II, MDContact: Alice Sheffet, PhD, CREST-Administrative Center, UMDNJ-New Jersey Medical School, 30 Bergen Street, ADMC 617, Newark, New Jersey 07017, USA. Phone 973-972-7718. Fax 973-972-8383. E-mail [email protected]Location: North AmericaNumber of Centers: 121Sponsor: National Institute of Neurological Disorders and Stroke, National Institutes of Health; Abbott Vascular, IncDates of Study: 2000 to 2011*CLOTS Trial (Clots in Legs or sTockings after Stroke): A randomized trial to establish the effectiveness of graduated compression stockings to prevent poststroke deep-vein thrombosis.The CLOTS Trial is a family of 2 multicenter, international, partially blinded, randomized controlled trials which aim to establish the effectiveness of graduated compression stockings (GCS) to prevent poststroke deep-vein thrombosis (DVT). Trial 1 is comparing full-length GCS with no GCS, whilst Trial 2 is comparing full-length and below-knee GCS. Centers randomize consenting patients into either Trial 1 or 2 depending on their current practice and beliefs with respect to GCS after stroke. Patients who are admitted to hospital within 1 week of an acute stroke and are immobile can be randomized into CLOTS. The allocated type of GCS is applied to both legs as soon as possible after randomization and worn until the patient is independently mobile around the ward or until they are discharged from hospital or until the patient declines to wear them. Patients undergo a routine Doppler ultrasound of both legs at 7, and wherever possible, 30 days postrandomization. The primary outcomes are the presence of DVT in the popliteal vein or more proximal vein detected on either Doppler ultrasound or venography within 7 and 30 days of randomization. Patients are followed-up at 6 months to identify late events, survival and functional status.Chief Investigator: Professor Martin Dennis, Neurosciences Trials Unit, Western General Hospital, Crewe Road, Edinburgh UK. EH4 2XU. Phone 44 (0)131 5371082 Fax 44 (0)131 332 5150, E-mail [email protected], Website: www.clotstrial.comLocation: Europe, Australia, India, Canada, MexicoNumber of Centers: 83. We estimate we will need to enroll at least 1500 patients in Trial 1 and 2500 in Trial 2, and are actively seeking collaborating centers.Sponsor: Medical Research Council (UK)Dates of Study: 2001–2009*The Continue Or Stop post-Stroke Antihypertensives Collaborative Study (COSSACS)Summary: Up to 40% of acute stroke patients on hospital admission are already taking antihypertensive therapy, and most will develop elevated blood pressure levels as an acute complication of the stroke. However, no guidelines exist as to whether antihypertensive therapy should be continued or discontinued after acute stroke. The Continue Or Stop post-Stroke Antihypertensives Collaborative Study (COSSACS) is a multicenter, prospective, randomized, open, blinded-end point study to assess whether existing antihypertensive therapy should be continued or discontinued within 48 hours of stroke onset and for the subsequent 2 weeks. A study population of 2900 patients with both cerebral infarction and hemorrhage on antihypertensive treatment at hospital admission will be recruited giving the study a 90% power at the 5% significance level to detect a relative reduction of 10% (absolute risk reduction of 6%) in death and dependency between continuation and discontinuation groups at 2 weeks. Nondysphagic, hospital-admitted stroke patients will be recruited within 48 hours of stroke onset and also within 24 hours of last dose of pre-existing antihypertensive therapy. Baseline investigations will include blood pressure measurement using UA-767 monitor, modified Rankin Scale score, Barthel Index, National Institutes of Health Stroke Score and Oxfordshire Community Stroke Project Classification. Patients will be centrally randomized by secure website to continue or discontinue pre-existing antihypertensive treatment for a 2-week period. Blood pressure, modified Rankin Scale score, Barthel Index and National Institutes of Health Stroke Score will be repeated at 2 weeks by an observer blinded to the randomized group. Mortality and health-related quality of life outcomes will be centrally recorded at 6 months. The primary outcome will be death or dependency (modified Rankin Scale score >3) at 2 weeks postrandomization. Early secondary outcomes of neurological deterioration, functional status, blood pressure changes from admission and discharge destination will be recorded at 2 weeks. Late secondary outcome measures of death and dependency, fatal and nonfatal stroke recurrence, functional status, health-related quality of life and discharge destination will be recorded at 6 months.Principal Investigators: Dr T.G. Robinson and Professor J.F. PotterContact Details: Department of Cardiovascular Sciences, Ageing and Stroke Medicine Group, University of Leicester, University Hospitals of Leicester NHS Trust, Gwendolen Road, Leicester LE5 4PW. Phone +44 (0)116 258 4223. Fax 0 +44 (0)116 258 4187. E-mail: [email protected]Location: United KingdomSponsor: The Health FoundationDate of Study: December 2002 (ongoing)Controlling Hypertension and Hypotension Immediately Post-Stroke (CHHIPS) TrialFollowing acute stroke up to 60% of patients will be hypertensive (SBP ≥160 mm Hg) and nearly 20% hypotensive (SBP 160 mm Hg), and treatment <12 hours. Randomization and data registration are performed over the Internet. Centers are invited to join the collaborative group. 615 patients had been recruited by May 2006.Principal Investigator: Philip M.W. Bath, MD FRCPContact: P.M.W. Bath, ENOS Trial Centre, Division of Stroke Medicine, University of Nottingham, City Hospital Campus, Nottingham NG5 1PB, UK. Phone 44-115-823-1768. Fax 44-115-823-1771. E-mail [email protected] Internet: http://www.enos.ac.uk/Location: GlobalNumber of Centers: 46, looking for 200Sponsor: UK Medical Research Council (previously BUPA Foundation, The Hypertension Trust, University of Nottingham)Dates of Study: July 2001 to October 2011Evaluation of the STARflex Septal Closure System in Patients with a Stroke or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a PFO (CLOSURE)CLOSURE is a prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the STARflex Septal Closure System versus aspirin and/or warfarin therapy for the prevention of stroke, TIA and mortality in patients with an initial stroke or TIA due to a presumed paradoxical embolism through a patent foramen ovale (PFO). The goal is to determine whether device closure of a PFO is superior to best medical therapy for preventing recurrent stroke or TIA in patients with an initial cryptogenic stroke/TIA and a PFO. Sixteen hundred patients (800 in each group) at up to 100 sites nationally will be randomized within 180 days of the entry event. Study patients will be followed for 2 years. All strokes and TIAs will be adjudicated by a blinded Clinical Events Committee using prespecified clinical and MR imaging definitions. The primary end point of incidence of 24-month stroke or TIA, all cause mortality for the first 30 days of follow-up or hospital discharge, whichever is longer, and neurological mortality from ≥31 days of follow-up will be analyzed on an intent-to-treat basis using the χ2 test and logistic regression adjusting for study center and demographic characteristics deemed related to the primary end point. Safety analyses will focus on the incidence of severe adverse events related to either device insertion or major bleeding complications on medical therapy.Principal Investigator: Anthony J. Furlan MDCo-Principal Investigator: Marc Reisman MDExecutive Committee: A.J. Furlan, M. Reisman, H. Adams, L. Wechsler, Gregory Albers, Robert Felberg, M. Landzberg, H. Hermann, Al Raizner, Saibal KarData Safety Monitoring Board: J. P. Mohr, ChairmanClinical Events Committee: Marc Fisher, ChairmanData Management: Harvard Clinical Research InstituteContact: A.J. Furlan, Cleveland Clinic Department of Neurology, S91, 9500 Euclid Avenue, Cleveland, Ohio 44195. Fax 216 444 0232. Phone 216 444 5535. E-mail [email protected]Sponsor: NMT Medical, 27 Wormwood St., Boston MA 02210-1625Dates of Study: July 2003 to July 2006*The Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Phase 3 TrialMagnesium is neuroprotective in preclinical models of stroke and has been safe and shown signals of potential efficacy when administered early after onset in initial human stroke clinical trials. Delayed initiation of neuroprotective agents has hindered past phase 3 neuroprotective agent trials. The purpose of the FAST-MAG phase 3 trial is to demonstrate that paramedic initiation of intravenous magnesium sulfate within 2 hours of symptom onset improves the long-term functional outcome of hyperacute stroke patients.FAST-MAG is a multicenter, randomized, double-blind, placebo-controlled phase 3 trial that will enroll 1298 patients (649 in each arm). The study population consists of prehospital patients with acute stroke, including both cerebral infarction and intracerebral hemorrhage patients. Inclusion criteria: (1) likely stroke as identified by the Los Angeles Prehospital Stroke Screen (LAPSS), (2) age 40 to 95, (3) symptom onset within 2 hours of treatment initiation, (4) deficit present ≥15 minutes. Study agent will be started within 1 hour of onset in ≈1/2 of enrolled patients and between 1 to 2 hours after onset in the remainder. Study sites are up to 80 ambulance-receiving hospitals in Los Angeles County, serviced by the LA County EMS Agency. In the study intervention, paramedics administer a loading dose of magnesium sulfate (Mg) or matched placebo in the field, 4 grams over 15 minutes. In the ED, a maintenance infusion follows, 16 grams Mg or matched placebo over 24 hours. Explicit informed consent is obtained in the field by phone physician contact, either from competent patients or on scene legally authorized representatives, using an in-vehicle FAST-MAG cellular phone.The primary end point is the distribution of scores across all 7 strata of the modified Rankin Scale global measure of functional outcome, assessed 90 days after treatment. Secondary end points include NIHSS (neurologic deficit), Barthel Index (disability), and Stroke Impact Scale (quality of life).Principal Investigator: Jeffrey L. Saver, MDCo-Principal Investigators: Sidney Starkman, MD; Sam Stratton, MD; Chelsea Kidwell, MD; Marc Eckstein, MDContact: Jeffrey L. Saver, MD, Professor of Neurology, UCLA Stroke Center, 710 Westwood Plaza, Los Angeles, CA 90095. Phone 310-794-6379. Fax 310-267-2063. E-mail [email protected]Location: Los Angeles CountyNumber of Centers: Up to 80Sponsor: National Institute of Neurologic Disorders and Stroke-National Institutes of HealthDates of Study: 2003–2008*Global Carotid Artery Stent RegistryThis registry is an expanding multicenter, retrospective study to determine the benefits and risks of percutaneous transluminal angioplasty with stent placement of the cervical carotid arteries in patients with cerebrovascular disease. The basic intent of the survey is to evaluate the growth of carotid stent placement and obtain an early review of its results, including stent procedures, technical success, and types of stems placed. In addition, complications such as TIAs, minor and major strokes, and deaths for symptomatic and asymptomatic patients will be studied. Long-term follow-up involving restenosis rates and neurological events will be monitored.Principal Investigator: Michael H. Wholey, MD, MBAContact: Michael H. Wholey, MD, MBA, Department of Radiology, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78284. Phone 210-567-6433. Fax 210-567-5541. E-mail [email protected]Location: GlobalNumber of Centers: Currently 30, looking for l00+. Recruitment criteria is a minimum of 15 carotid stent procedures performed to date. Open to all interventional specialists.Sponsor: NoneDates of Study: June 1997 (continuing)Increasing Stroke treatment through Interventional Behavior Change Tactics (INSTINCT)The INcreasing Stroke Treatment through Interactive behavioral Change Tactic (INSTINCT) trial is a multicenter, randomized, controlled study designed to evaluate the effectiveness of a standardized, system-based, barrier assessment and interactive educational intervention (BA-IEI) approach to increase appropriate tPA use in stroke. The intervention is based on adult education and behavior change theory, targets emergency departments and hospital systems, and is designed for replication in community health initiatives. It incorporates local stroke champion development, hospital-specific barrier evaluation, mixed CME modules targeting identified barriers, performance feedback, protocol development, and academic detailing. The primary end point will be the increase in appropriate use of tPA in stroke with evaluations of change in emergency physician knowledge on tPA use.Principal Investigator: Phillip A. Scott, MDContact: Shirley Frederiksen, MS, RN, Project Manager, 24 Frank Lloyd Wright Dr, Lobby H Box 381, Ann Arbor, MI 48106. Phone 734-232-2142.Location: University of Michigan Department of Emergency Medicine.Number of Centers: 24Sponsor: National Institute for Neurological Disorders and Stroke, National Institutes of Health.Dates of Study: July 2005 to July 2010.*International Carotid Stenting Study (ICSS)ICSS is a randomized, multicenter trial to compare the risks of treatment and benefits in the prevention of stroke of primary carotid stenting in comparison with conventional carotid endarterectomy.Principal Investigator: M.M. Brown, MDContact: Martin M. Brown, MD, FRCP, Professor of Stroke Medicine, Institute of Neurology, Box 6, The National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N 3BG, UK. Phone 44-20-7829-8753. Fax 44-20-7833-8613Location: Europe, North America, Australia and New ZealandNumber of Centers: 49. New centers welcomeSponsor: University College LondonDates of Study: Recruitment started in 2001.Web Address: www.cavatas.com*Intra-Arterial Versus Intravenous Thrombolysis In Acute Ischemic Stroke (SYNTHESIS)SYNTHESIS is a multicenter RCT, open-label, with blinded follow-up aiming to determine whether locoregional intra-arterial (IA) alteplase, as compared with systemic intravenous (IV) infusion of the same drug within 3 hours of ischemic stroke, increases the proportion of independent survivors at 3 months. Eligibility applies to patients with symptomatic, CT verified, acute ischemic strokes being able to initiate IV alteplase within 3 hours and IA alteplase within 6 hours of stroke onset when uncertainty about appropriateness of the 2 approaches exists as established by the treating physician. Eligible patients are randomized to receive either 0.9 mg/kg (max 90 mg) IV alteplase (control arm) or up to 0.9 mg/kg IA alteplase (max 90 mg) over 60 minutes into the thrombus eventually associated with clot mechanical disruption and/or retrieval. The study is designed to detect or disprove (α=5% and power probability=80%) a 15% absolute difference between the treatment groups in the percentage of patients with a favourable outcome (modified Rankin Scale score =0 to 1). Enrollment will be completed with 350 randomized patients.Principal Investigator: A. CicconeSteering Committee:Neurology: A. Ciccone, A. Gatti, A. Guccione, M. Magoni, I. Santilli, M. Sessa, R. Sterzi. Interventional Neuroradiology: L. Valvassori, F. Scomazzoni, R. Gasparotti, E. BoccardiSafety and Monitoring Committee: L. Cande
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