EXCEED THE SPACE PROVIDED. Stent assisted carotid percutaneous transluminal angioplasty (SACPTA) is a relatively new procedure that has been used increasingly in recent years. Its growth is due, at least in part, to the perceived advantages of a less invasive treatment for extracranial carotid occlusive disease. However, data contrasting the efficacy of SACPTA and carotid endarterectomy (CEA), the gold standard treatment for carotid atherosclerosis, are not available. Current reports are either non-randomizec comparisons, or retrospective clinical studies. The Carotid RevascularizationEndarterectomy versus Stent Trial (CREST) contrasts the-rtSlfe-flVte^fficacyof SACPTA with CEA in preventing stroke, myocardial infarction or death during a 30-day peri-procedural period, or ipsilateral stroke ove the follow-up period extending up to four years. Stroke events will be verified by an Adjudication Committee masked to the assigned treatment. Secondary outcomes include:(1) describe differential efficacy of SACPTA and CEA in men and women, (2) contrast peri-procedural (30-day) morbidity and post-procedural (after 30-days) morbidity and mortality (3 estimate and contrast the restenosis rates of the two procedures, (4) evaluate differences in measures of health related quality of life andcost effectiveness , and (5) identify subgroups of participants at differential risk for SACPTA and CEA The primary eligibility criterion is a high grade U70%) stenosis of the carotid artery in patients with transient ischemic attack or ipsilateral non-disabling stroke. Men and women will be eligible for the trial, but patients with medical conditions ikely to limit their participation during the follow-up or to interfere with outcome evaluation will be excluded. After a credentialing and training phase, 2,200 patients will be randomizedto the treatments. Statistical analysis of the primary outcome will employ standard survival techniques, and will result in 90% power to detect annual differences between groups of ^1.2% in event rates of the primary outcomes. PERFORMANCE SITE ========================================Section End===========================================

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
3R01NS038384-06S1
Application #
7127555
Study Section
Special Emphasis Panel (ZRG7)
Program Officer
Cordell, Janice
Project Start
1999-01-15
Project End
2006-12-31
Budget Start
2005-01-01
Budget End
2006-12-31
Support Year
6
Fiscal Year
2005
Total Cost
$155,500
Indirect Cost
Name
University of Medicine & Dentistry of NJ
Department
Surgery
Type
Schools of Medicine
DUNS #
623946217
City
Newark
State
NJ
Country
United States
Zip Code
07107
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Brott, Thomas G; Howard, George; Roubin, Gary S et al. (2016) Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis. N Engl J Med 374:1021-31
Moore, Wesley S; Popma, Jeffrey J; Roubin, Gary S et al. (2016) Carotid angiographic characteristics in the CREST trial were major contributors to periprocedural stroke and death differences between carotid artery stenting and carotid endarterectomy. J Vasc Surg 63:851-7, 858.e1
Hye, Robert J; Voeks, Jenifer H; Malas, Mahmoud B et al. (2016) Anesthetic type and risk of myocardial infarction after carotid endarterectomy in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). J Vasc Surg 64:3-8.e1
Darger, Bryan; Gonzales, Nicole; Banuelos, Rosa C et al. (2015) Outcomes of Patients Requiring Blood Pressure Control Before Thrombolysis with tPA for Acute Ischemic Stroke. West J Emerg Med 16:1002-6
Howard, George; Hopkins, L Nelson; Moore, Wesley S et al. (2015) Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial. Stroke 46:2183-9
Sheffet, Alice J; Voeks, Jenifer H; Mackey, Ariane et al. (2015) Characteristics of participants consenting versus declining follow-up for up to 10?years in a randomized clinical trial. Clin Trials 12:657-63
Meschia, James F; Hopkins, L Nelson; Altafullah, Irfan et al. (2015) Time From Symptoms to Carotid Endarterectomy or Stenting and Perioperative Risk. Stroke 46:3540-2
Malas, Mahmoud; Glebova, Natalia O; Hughes, Susan E et al. (2015) Effect of patching on reducing restenosis in the carotid revascularization endarterectomy versus stenting trial. Stroke 46:757-61

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