Study Stopped
Business decision and not a result of any patient or product safety issues.
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)
ACT I
1 other identifier
interventional
1,663
1 country
62
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2005
Longer than P75 for not_applicable
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2005
CompletedStudy Start
First participant enrolled
April 1, 2005
CompletedFirst Posted
Study publicly available on registry
April 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
October 21, 2014
CompletedJuly 19, 2017
June 1, 2017
7.9 years
April 1, 2005
April 2, 2014
June 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.
0 to 365 days
Secondary Outcomes (32)
Acute Device Success: Xact Carotid Stent
On day 0 after index procedure
Acute Device Success: Embolic Protection Device System
On day 0 after index procedure
Procedural Success
0 to 30 days post procedure
Composite Morbidity Measure
0 to 30 Days Post-procedure
Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)
0 to 180 days
- +27 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORCAS 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.
2
ACTIVE COMPARATORCEA 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.
Interventions
Carotid artery stenting with filter (interventional)
Eligibility Criteria
You may qualify if:
- The subject must be \> 18 and \< 80 years of age.
- Female subjects of child bearing potential must have a documented negative pregnancy test within 30 days prior to the study procedure.
- Subject must be asymptomatic, defined as no stroke or Transient Ischemic Attack \[(TIA);(hemispheric or ocular)\] within the 180 days prior to the procedure. Subjects who have experienced these neurological symptoms prior to the 180 day pre-procedure window will be eligible for enrollment. An independent study neurologist or independent study neurosurgeon must confirm the subject's neurological status.
- Subjects taking warfarin may be included if their dosage is reduced before the procedure to result in an International Normalized Ratio (INR) of 1.5 or less. Warfarin may be restarted after the procedure.
- The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local institutional review board (IRB).
- The subject must agree to return for all required follow-up visits.
- Subject has a discrete lesion located in the internal carotid artery (ICA); the contiguous common carotid artery (CCA) may be involved.
- Carotid stenosis ≥ 70% and ≤ 99% by carotid ultrasound or ≥ 70% and ≤ 99% stenosis (visual estimate) by angiography, without significant (\> 60% by ultrasound or angiography) ICA/CCA contralateral stenosis.
- Target ICA vessel diameter must be visually estimated to be:
- \> 2.5 mm and \< 7.0 for the Emboshield Pro or for the Emboshield NAV6, \> 2.8 mm and \< 6.2 for the Emboshield Gen 3 And \> 4.0 mm and \< 9.0 mm for the Xact stent treatment segment. An untreated contralateral ICA may be used for visual estimation when a highly stenosed lesion makes measurement of the target vessel inaccurate.
- Based on the subject's anatomy, the Investigator should expect to successfully deliver the stent to the target lesion (absence of extreme tortuosity, etc.).
- De novo target lesion that can be treated with a single stent.
You may not qualify if:
- Subject is symptomatic and has had a stroke or exhibited TIA (hemispheric or ocular) within 180 days prior to randomization, which has been confirmed by an independent study neurologist or independent study neurosurgeon.
- Subject is participating in another drug or device trial (IND or IDE) that has not completed the primary endpoint or that may potentially confound the results of this trial. Subject may be enrolled only once in this trial and may not participate in any other clinical trial during a 1-year period post-index procedure.
- Subject has inability to understand and cooperate with study procedures or provide informed consent.
- Subject has had an intracranial hemorrhage or hemorrhagic stroke within 1-year prior the index procedure.
- Subject has dementia or has a neurological illness that may confound the neurological evaluation.
- Subject has had a known untoward reaction to anesthesia or contrast media not able to be overcome by pre-treatment with medications.
- Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and Clopidogrel/Ticlopidine.
- Subject has Hemoglobin (Hgb) less than 10 gm/dL, platelet count \<100,000/mm3 or \>500,000/mm3, or known heparin associated thrombocytopenia.
- Subject has an active bleeding diathesis or coagulopathy, or will refuse blood transfusions.
- Subject has had a GI bleed that would interfere with antiplatelet therapy.
- Subject has known cardiac sources of emboli, including paroxysmal or sustained atrial fibrillation (treated or untreated).
- Subject has had an myocardial infarction (MI) within the previous 30 days.
- Subject has any condition that limits their anticipated survival to less than 3 years.
- Subject is a high risk surgical candidate defined as the presence of any one or more of a following medical conditions:
- Two or more proximal diseased coronary arteries of \> 70% stenosis that have not or cannot be revascularized or \< 30 days since revascularization.
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
St. Luke's Hospital-Phoenix
Phoenix, Arizona, 85006, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
Fogarty Clinical Research Inc./El Camino Hospital
Mountain View, California, 94040, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
St. Joseph Hospital
Orange, California, 92868, United States
Kaiser Foundation Hospital-San Diego
San Diego, California, 92120, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Hawaii Permanente Medical Group - Kaiser
Honolulu, Hawaii, 96817, United States
Northwestern University Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
St. John's Hospital and Memorial Medical Center/ Prairie Heart Cooperative
Springfield, Illinois, 62701, United States
Parkview Hospital
Fort Wayne, Indiana, 46805, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
University of Louisville
Louisville, Kentucky, 40292, United States
Cardiovascular Institute of the South
Lafayette, Louisiana, 70506, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Harper University Hospital/Detroit Medical Center
Detroit, Michigan, 48201, United States
McLaren Regional Medical Center
Flint, Michigan, 48507, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Our Lady of Lourdes Medical Center
Camden, New Jersey, 08103, United States
Albany Medical Center
Albany, New York, 12208, United States
Millard Fillmore Hospital
Buffalo, New York, 14209, United States
NYU Medical Center
New York, New York, 10016, United States
Columbia Presbyterian Hospital
New York, New York, 10021, United States
Lenox Hill Hospital
New York, New York, 10021, United States
University of Rochester-Strong Memorial Hospital
Rochester, New York, 14623, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Duke University Medical Center
Durham, North Carolina, 27609, United States
WakeMed Health and Hospital
Raleigh, North Carolina, 27610, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Oregon Health and Science University Stroke Center
Portland, Oregon, 97239, United States
Heritage Valley Health System
Beaver, Pennsylvania, 15009, United States
Harrisburg Hospital / Pinnacle Health
Harrisburg, Pennsylvania, 17110, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Physicians Division of Vascular Surgery/Shadyside Medical
Pittsburgh, Pennsylvania, 15232, United States
Allegheny General Hospital
Washington, Pennsylvania, 15301, United States
St. Joseph's Medical Center/Berks Cardiologists
Wyomissing, Pennsylvania, 19610, United States
Providence Hospital-SC
Columbia, South Carolina, 29204, United States
North Central Heart Institute
Sioux Falls, South Dakota, 57108, United States
The Stern Cardiovascular Center/Methodist Germantown Hospital
Germantown, Tennessee, 38138, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
Mercy Medical West/Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Westlake Medical Center/Seton Heart Institute
Austin, Texas, 78705, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Dallas Veteran's Administration Medical Center
Dallas, Texas, 75216, United States
Presbyterian Hospital of Dallas
Dallas, Texas, 75231, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Chesapeake General Hospital/Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
St. Mary's Hospital / Virginia Cardiovascular Specilists
Richmond, Virginia, 23226, United States
Deaconess Medical Center
Spokane, Washington, 99204, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
St. Luke's Medical Center - Milwaukee
Milwaukee, Wisconsin, 53215, United States
Related Publications (2)
Weinberg I, Beckman JA, Matsumura JS, Rosenfield K, Ansel GM, Chaturvedi S, Gray W, Metzger DC, Riles T, Shu Y, Wechsler L, Jaff MR. Carotid Stent Fractures Are Not Associated With Adverse Events: Results From the ACT-1 Multicenter Randomized Trial (Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease). Circulation. 2018 Jan 2;137(1):49-56. doi: 10.1161/CIRCULATIONAHA.117.030030. Epub 2017 Oct 5.
PMID: 28982691DERIVEDRosenfield K, Matsumura JS, Chaturvedi S, Riles T, Ansel GM, Metzger DC, Wechsler L, Jaff MR, Gray W; ACT I Investigators. Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis. N Engl J Med. 2016 Mar 17;374(11):1011-20. doi: 10.1056/NEJMoa1515706. Epub 2016 Feb 17.
PMID: 26886419DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer M Jones-McMeans, PhD (Associate Director Clinical Research)
- Organization
- Abbott Vascular
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Matsumura, MD
University of Wisconsin, Madison
- PRINCIPAL INVESTIGATOR
Kenneth Rosenfield, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2005
First Posted
April 4, 2005
Study Start
April 1, 2005
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
July 19, 2017
Results First Posted
October 21, 2014
Record last verified: 2017-06