Carotid Stenting vs. Surgery of Severe Carotid Artery Disease and Stroke Prevention in Asymptomatic Patients (ACT I)

This study has been terminated.
(Business decision by the sponsor and not a result of any patient or product safety issues.)
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00106938
First received: April 1, 2005
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® 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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Occurrence of major adverse events 30 days following the procedure [ Time Frame: 0 to 365 days post procedure ] [ Designated as safety issue: Yes ]
    Major adverse events = Composite of any stroke, myocardial infarction and death during the 30-day post-procedural period and ipsilateral strokes between 31 and 365 days post-procedure.


Secondary Outcome Measures:
  • Acute device success [ Time Frame: 0 to 30 days post procedure ] [ Designated as safety issue: Yes ]
  • Procedural success [ Time Frame: 0 to 30 days post procedure ] [ Designated as safety issue: No ]
  • Composite Morbidity Measure [ Time Frame: 0 to 30 Days Post-procedure ] [ Designated as safety issue: Yes ]
    Composite Morbidity Measure = Cranial and peripheral nerve injury (cranial/cervical, femoral, peroneal, or other), vascular injury (including CAS access artery injury), non-cerebral bleeding, hematoma, or pseudoaneurysm, CEA wound or access artery wound, general anesthesia/allergic reaction/airway complications.

  • Freedom from clinically indicated target lesion revascularization [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Freedom from clinically indicated target lesion revascularization [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Freedom from ipsilateral stroke [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
  • Freedom from ipsilateral stroke [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
  • Freedom from ipsilateral stroke [ Time Frame: at 4 years ] [ Designated as safety issue: Yes ]
  • Freedom from ipsilateral stroke [ Time Frame: at 5 years ] [ Designated as safety issue: Yes ]
  • Freedom from mortality [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  • Freedom from mortality [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
  • Freedom from mortality [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
  • Freedom from mortality [ Time Frame: at 4 years ] [ Designated as safety issue: Yes ]
  • Freedom from mortality [ Time Frame: at 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 1665
Study Start Date: April 2005
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

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)
Active Comparator: 2

CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

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)

Detailed Description:

Randomization for ACT 1 employs a 3:1 ratio of CAS versus CEA. A lead-in phase of up to 400 carotid stent subjects will provide investigators experience with the study devices prior to pivotal enrollment.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe carotid artery disease
  • Patients who have not had symptoms related to their carotid artery disease in the last 180 days
  • Patients who are able to undergo either an interventional stenting or surgical procedure

Exclusion Criteria:

  • Patients who have had symptoms in the last 180 days
  • Patients who are high risk for surgery
  • Patients who have certain conditions that might confound the results of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106938

  Hide Study Locations
Locations
United States, Arizona
St. Luke's Hospital-Phoenix
Phoenix, Arizona, United States, 85006
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, California
Fogarty Clinical Research Inc./El Camino Hospital
Mountain View, California, United States, 94040
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
St. Joseph Hospital
Orange, California, United States, 92868
Kaiser Foundation Hospital-San Diego
San Diego, California, United States, 92120
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Hawaii
Hawaii Permanente Medical Group - Kaiser
Honolulu, Hawaii, United States, 96817
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Northwestern University Memorial Hospital
Chicago, Illinois, United States, 60611
St. John's Hospital and Memorial Medical Center/ Prairie Heart Cooperative
Springfield, Illinois, United States, 62701
United States, Indiana
Parkview Hospital
Fort Wayne, Indiana, United States, 46805
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
University of Louisville
Louisville, Kentucky, United States, 40292
United States, Louisiana
Cardiovascular Institute of the South
Lafayette, Louisiana, United States, 70506
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Harper University Hospital/Detroit Medical Center
Detroit, Michigan, United States, 48201
McLaren Regional Medical Center
Flint, Michigan, United States, 48507
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Missouri
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Our Lady of Lourdes Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Millard Fillmore Hospital
Buffalo, New York, United States, 14209
Lenox Hill Hospital
New York, New York, United States, 10021
Columbia Presbyterian Hospital
New York, New York, United States, 10021
NYU Medical Center
New York, New York, United States, 10016
University of Rochester-Strong Memorial Hospital
Rochester, New York, United States, 14623
St. Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27609
WakeMed Health and Hospital
Raleigh, North Carolina, United States, 27610
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Oregon
Oregon Health and Science University Stroke Center
Portland, Oregon, United States, 97239
United States, Pennsylvania
Heritage Valley Health System
Beaver, Pennsylvania, United States, 15009
Harrisburg Hospital / Pinnacle Health
Harrisburg, Pennsylvania, United States, 17110
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Physicians Division of Vascular Surgery/Shadyside Medical
Pittsburgh, Pennsylvania, United States, 15232
Allegheny General Hospital
Washington, Pennsylvania, United States, 15301
St. Joseph's Medical Center/Berks Cardiologists
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Providence Hospital-SC
Columbia, South Carolina, United States, 29204
United States, South Dakota
North Central Heart Institute
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
The Stern Cardiovascular Center/Methodist Germantown Hospital
Germantown, Tennessee, United States, 38138
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660
Mercy Medical West/Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
United States, Texas
Heart Hospital of Austin
Austin, Texas, United States, 78756
Westlake Medical Center/Seton Heart Institute
Austin, Texas, United States, 78705
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Dallas Veteran's Administration Medical Center
Dallas, Texas, United States, 75216
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
United States, Virginia
Chesapeake General Hospital/Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
St. Mary's Hospital / Virginia Cardiovascular Specilists
Richmond, Virginia, United States, 23226
United States, Washington
Deaconess Medical Center
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
St. Luke's Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Jon Matsumura, MD University of Wisconsin, Madison
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00106938     History of Changes
Other Study ID Numbers: AVD-640-0052
Study First Received: April 1, 2005
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Carotid stenting
Carotid endarterectomy
Carotid artery disease with severe narrowing of the artery
Stroke prevention

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Atherosclerosis
Arteriosclerosis
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014