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| Sponsor: | Abbott Vascular |
|---|---|
| Information provided by: | Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT00106938 |
Purpose
The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System and Emboshield® Pro Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Carotid Artery Disease Carotid Stenosis Stroke Atherosclerosis |
Device: Carotid artery stenting with filter (interventional) Procedure: Carotid artery endarterectomy (surgical) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I) |
| Estimated Enrollment: | 1658 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | May 2018 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). A lead-in phase of up to 400 carotid stent subjects will provide investigators experience with the study devices prior to pivotal enrollment. Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years. |
Device: Carotid artery stenting with filter (interventional)
Carotid artery stenting with filter (interventional)
|
|
2: Active Comparator
CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). A lead-in phase of up to 400 carotid stent subjects will provide investigators experience with the study devices prior to pivotal enrollment. Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years. |
Procedure: Carotid artery endarterectomy (surgical)
Carotid artery endarterectomy (surgical)
|
Patients will be randomized to either an interventional treatment using a carotid artery stent and filter or the surgical procedure of carotid endarterectomy, on a 3:1 basis. This means that three interventional procedures will be conducted to each surgical (CEA) one, on average, for every four patients.
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sandy Lee | 408-845-0516 | Sandy.Lee@av.abbott.com |
Hide Study Locations| United States, Arizona | |
| St. Luke's Hospital-Phoenix | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Linda Iovanni 602-234-0004 lindaiovanni@rcrsolutions.org | |
| Principal Investigator: Richard Heuser, MD | |
| Mayo Clinic | Recruiting |
| Phoenix, Arizona, United States, 85054 | |
| Contact: Kerry Brennan 480-342-2131 Brennan.kerry@mayo.edu | |
| Principal Investigator: Maria Aguilar, MD | |
| United States, California | |
| Hoag Memorial Hospital | Recruiting |
| Newport Beach, California, United States, 92663 | |
| Contact: Carol Moore, RN 949-764-5587 carol.moore@hoaghospital.org | |
| Principal Investigator: Subbarao Myla, MD | |
| Kaiser Foundation Hospital-San Diego | Recruiting |
| San Diego, California, United States, 92120 | |
| Contact: Sonni Longson, CCRC 619-528-5503 Sonni.X.Longson@kp.org | |
| Principal Investigator: Robert Hye, MD | |
| St. Joseph Hospital | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Doreen Robinson 717-560-4450 doreen@visoc.org | |
| Principal Investigator: Mahmood Razavi, MD | |
| Cardiovascular Institute / El Camino Hospital | Recruiting |
| Mountain View, California, United States, 94040 | |
| Contact: Betty de Bettencourt, RN 650-969-8604 bdebetten@yahoo.com | |
| Principal Investigator: James Joye, DO, FACC | |
| United States, District of Columbia | |
| Washington Hospital Center | Active, not recruiting |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Baptist Cardiac and Vascular Institute | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Sarah Orendorf-Alegre, RN 786-596-5336 saraho@baptisthealth.net | |
| Principal Investigator: Barry Katzen, MD | |
| United States, Hawaii | |
| Hawaii Permanente Medical Group - Kaiser | Recruiting |
| Honolulu, Hawaii, United States, 96819 | |
| Contact: Cyndee Yonehara 808-432-4759 cyndee.h.yonehara@kp.org | |
| Principal Investigator: Peter Schneider, MD | |
| United States, Illinois | |
| St. John's Hospital and Memorial Medical Center/ Prarie Heart Cooperative | Recruiting |
| Springfield, Illinois, United States, 62769 | |
| Contact: Shannon Wilson, RN 217-492-9100 swilson@prairieresearch.com | |
| Principal Investigator: Gregory J Mishkel, M.D. | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Amy Graf 312-942-6000 Amy_M_Graf@rush.edu | |
| Principal Investigator: Jeffery Snell, MD | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Anna Busman 312-695-3410 abusman@nmh.org | |
| Principal Investigator: Mark Eskandari, MD | |
| United States, Indiana | |
| Parkview Hospital | Recruiting |
| Fort Wayne, Indiana, United States, 46805 | |
| Contact: Tammy Morken 260-373-8176 tammy.morken@parkview.com | |
| Principal Investigator: Hollace Chastain, MD | |
| St. Vincent's Hospital | Withdrawn |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Cheri Abadie, RN 504-842-5071 cabadie@ochsner.org | |
| Principal Investigator: Stephen Ramee, MD | |
| Cardiovascular Institute of the South | Active, not recruiting |
| Lafayette, Louisiana, United States, 70506 | |
| United States, Maine | |
| Cape Cod Research Institute | Withdrawn |
| Hyannis, Maine, United States, 02601 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Debbie O'Shaughnessy, RN 617-726-3057 doshaughnessy@partners.org | |
| Principal Investigator: Joseph Garasic, MD | |
| Sub-Investigator: Kenneth Rosenfield, MD | |
| United States, Michigan | |
| Detroit Medical Center | Active, not recruiting |
| Detroit, Michigan, United States, 48201 | |
| William Beaumont Hospital | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Heidi Carl 248-898-5252 HCarl@beaumont.edu | |
| Principal Investigator: Robert Safian, MD | |
| United States, Missouri | |
| St. John's Mercy Medical Center | Recruiting |
| St. Louis, Missouri, United States, 63141 | |
| Contact: Mary Lesko, RN 314-308-0997 mary.lesko@mercy.net | |
| Principal Investigator: Vito Mantese, MD | |
| United States, New Hampshire | |
| Dartmouth | Recruiting |
| Lebanon, New Hampshire, United States, 03756 | |
| Contact: Sharon Segel, RN 603-650-4763 sharon.m.segel@hitchcock.org | |
| Principal Investigator: Richard Powell, MD | |
| United States, New Jersey | |
| Our Lady of Lourdes Medical Center | Recruiting |
| Camden, New Jersey, United States, 08103 | |
| Contact: Julie Bettelli, RN 856-757-0502 jbettelli@cadvhearthouse.com | |
| Principal Investigator: Ronald Cohen, DO | |
| United States, New York | |
| Millard Fillmore Hospital | Recruiting |
| Buffalo, New York, United States, 14209 | |
| Contact: Maureen Donovan, RN 716-887-5200 mdonovan@buffns.org | |
| Principal Investigator: L. Nelson Hopkins, MD | |
| Albany Medical Center | Recruiting |
| Albany, New York, United States, 12208 | |
| Contact: Debbie Hill 518-452-2198 hilld@mail.amc.edu | |
| Principal Investigator: Manish Mehta, MD | |
| Columbia Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Ariel Hidalgo 212-342-3485 ah2575@columbia.edu | |
| Principal Investigator: William Gray, MD | |
| Lenox Hill Hospital | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Ian Dalangin 212-434-2404 idalangin@lenoxhill.net | |
| Principal Investigator: Gary Roubin, MD | |
| St. Francis Hospital | Recruiting |
| Roslyn, New York, United States, 11576 | |
| Contact: Carol O'Brien, RN 516-562-6754 carol.o'brien@chsli.org | |
| Principal Investigator: George Petrossian, MD | |
| University of Rochester-Strong Memorial Hospital | Recruiting |
| Rochester, New York, United States, 14618 | |
| Contact: Mary Dowling 585-279-5195 mary_dowling@urmc.rochester.edu | |
| Principal Investigator: Karl Illig, MD | |
| NYU Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Jacqueline Bott 212-263-2268 jacqueline.bott@nyumc.org | |
| Principal Investigator: Neal Cayne, MD | |
| United States, North Carolina | |
| Forsyth Medical Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Deborah Wilson Norwood, RN 336-718-6045 dwnorwood@novanthealth.org | |
| Principal Investigator: Donald V Heck, MD | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Sophie Wang, RN 919-681-4680 sophie.wang@duke.edu | |
| Principal Investigator: James Zidar, MD | |
| Wake Medical Hospital | Recruiting |
| Raleigh, North Carolina, United States, 27610 | |
| Contact: Elizabeth Saylors 919-212-3875 eksaylors@wakeheartresearch.com | |
| Principal Investigator: Tift Mann, MD | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Jennifer Seaber 216-445-8063 seaberj@ccf.org | |
| Principal Investigator: Samir Kapadia, MD | |
| Riverside Methodist Hospital | Recruiting |
| Columbus, Ohio, United States, 43214 | |
| Contact: Amanda Bailey, RN 614-566-1257 abailey2@ohiohealth.com | |
| Principal Investigator: Gary Ansel, MD | |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Sarah Ross 503-494-7222 rosssar@ohsu.edu | |
| Principal Investigator: Wayne Clark, MD | |
| United States, Pennsylvania | |
| Harrisburg Hospital / Pinnacle Health | Recruiting |
| Harrisburg, Pennsylvania, United States, 17110 | |
| Contact: Roxanne Yost, RN 717-231-8815 ryost@ac-pc.com | |
| Principal Investigator: Rajesh Dave, M.D. | |
| Allegheny General Hospital | Active, not recruiting |
| Pittsburg, Pennsylvania, United States, 15212 | |
| Heritage Valley Health System | Recruiting |
| Beaver, Pennsylvania, United States, 15009 | |
| Contact: John Blanarik, MD 724-728-3302 jblanarik@hvhs.org | |
| Principal Investigator: Richard Begg, MD | |
| Hospital of the University of Pennsylvania | Withdrawn |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Berks Cardiologists / St. Joseph Medical Center | Recruiting |
| Wyomissing, Pennsylvania, United States, 19610 | |
| Contact: Kim Petersheim, RN 610-685-4843 kpetersheim@berkscardiologists.com | |
| Principal Investigator: Guy Piegari, MD | |
| United States, South Carolina | |
| Providence Hospital-SC | Active, not recruiting |
| Columbia, South Carolina, United States, 29204 | |
| United States, South Dakota | |
| North Central Heart Institute | Recruiting |
| Sioux Falls, South Dakota, United States, 57108 | |
| Contact: Patty Eisenbraun, RN 605-977-5336 research@ncheart.com | |
| Principal Investigator: Michael Bacharach, MD | |
| United States, Tennessee | |
| Baptist Hospital West | Recruiting |
| Knoxville, Tennessee, United States, 37920 | |
| Contact: Carla Staruk 865-218-7540 cfstaruk@mercy.com | |
| Principal Investigator: Malcolm Foster, MD | |
| Holston Valley Medical Center | Recruiting |
| Kingsport, Tennessee, United States, 37660 | |
| Contact: Josh Lester 423-230-5642 jlester@theheartcenter.net | |
| Principal Investigator: D. Christopher Metzger, MD | |
| The Stern Cardiovascular Center | Recruiting |
| Germantown,, Tennessee, United States, 38138 | |
| Contact: Janye Wilson, RN (901) 271-4165 jayne.wilson@sterncardio.com | |
| Principal Investigator: James E. Klemis, MD,FACC, FSCAI | |
| United States, Texas | |
| Presbyterian Heart Institute | Recruiting |
| Dallas, Texas, United States, 75237 | |
| Contact: Sylvia Moore 214-360-0869 SMoore@CIVADALLAS.COM | |
| Principal Investigator: Tony Das, MD | |
| St. Luke's Episcopal Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Aline Barzilla, RN 832-355-7734 abarzilla@sleh.com | |
| Principal Investigator: Neil Strickman, MD | |
| Austin Heart, P.A. | Recruiting |
| Austin, Texas, United States, 78756 | |
| Contact: Mary Robison, RN 512-421-3481 mrobison@austinheart.com | |
| Principal Investigator: Frank Zidar, MD | |
| Westlake Medical Center / Capital Cardiovascular Consultants Research Institute | Active, not recruiting |
| Austin, Texas, United States, 78746 | |
| United States, Virginia | |
| St. Mary's Hospital / Virginia Cardiovascular Specilists | Recruiting |
| Richmond, Virginia, United States, 23226 | |
| Contact: Kathleen Turner 804-282-2685 kturner@vacardio.com | |
| Principal Investigator: Charles Zacharias, MD | |
| Chesapeake General Hospital/Sentara Norfolk General Hospital | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Ellesia Wright, RN 757-622-2649 elwright2@sentara.com | |
| Principal Investigator: Rasesh Shah, MD | |
| United States, Washington | |
| Deaconess Medical Center | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Jason Krauss, RN 509-455-8820 Jkrauss@spokanecardiology.com | |
| Principal Investigator: Pierre Leimgruber, MD | |
| United States, Wisconsin | |
| St. Luke's Medical Center - Milwaukee | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Wendy Schmidt, RN 414-649-3512 wschmidt@hrtcare.com | |
| Principal Investigator: Tanvir Bajwa, MD | |
| Principal Investigator: | Jon Matsumura, MD | Northwestern Memorial Hospital |
| Principal Investigator: | Kenneth Rosenfield, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Abbott Vascular ( Matt Kiely ) |
| Study ID Numbers: | AVD-640-0052 |
| Study First Received: | April 1, 2005 |
| Last Updated: | September 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00106938 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Carotid stenting Carotid endarterectomy Carotid artery disease with severe narrowing of the artery Stroke prevention |
|
Atherosclerosis Arterial Occlusive Diseases Cerebral Infarction Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Arteriosclerosis |
Brain Diseases Cerebrovascular Disorders Carotid Stenosis Brain Ischemia Cardiovascular Diseases Brain Infarction Carotid Artery Diseases |
