Carotid Artery DiseaseACT INCT00106938

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)

A study testing Carotid artery stenting with filter (interventional) and Carotid artery endarterectomy (surgical) in people with Carotid Artery Disease and Carotid Stenosis, run by Abbott Medical Devices at 62 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Carotid Artery Disease, Carotid Stenosis, Stroke
What is being tested?: Carotid artery stenting with filter (interventional) and Carotid artery endarterectomy (surgical)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,663 participants
Where: 62 sitesUnited States
Study dates: Apr 2005to Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 12Show fewer

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.

Who cannot join

Each potential subject must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.
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.

Show all 44Show fewer

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.
Ejection fraction < 30% or New York Heart Association (NYHA) heart failure functional class 3 or higher.
Unstable angina, defined as angina at rest with ECG changes.
On a list for major organ transplant or is being evaluated for such.
Known history of respiratory insufficiency, forced expiratory volume (FEV1) < 30% (predicted).
Chronic renal insufficiency (serum creatinine >2.5 mg/dL).
Uncontrolled diabetes defined as fasting glucose > 400 mg/dL.
Concurrent requirement for any invasive procedure 30 days pre- or post-procedure.
Age ≥ 80 years.
Subject may be considered a non-surgical candidate for CEA as a result of one or more anatomic conditions or features which preclude normal surgical access or a high surgical risk because of the presence of any one or more anatomic conditions that present an increased potential for adverse events. These subjects are not eligible for enrollment.
Subject has had radiation treatment to the neck.
Subject has had a radical neck dissection.
Surgically inaccessible lesions (i.e., lesions extending above the level of C2).
Spinal immobility - inability to flex neck beyond neutral or kyphotic deformity.
Presence of carotid artery dissection, aneurysm, pseudoaneurysm, arteritis or fibromuscular dysplasia (FMD) in the target vessel.
Hemodynamically significant (>60%) stenosis of the right or left common carotid artery (LCCA/RCCA) below the clavicle.
Presence of tracheostomy stoma.
Contralateral laryngeal nerve paralysis.
Previous carotid endarterectomy, extracranial-intracranial or carotid subclavian bypass procedure ipsilateral to the carotid stenosis.
Severe hypertension (defined as blood pressure > Systolic of 180 mm Hg and/or a diastolic of 110 mm Hg) not adequately controlled by anti-hypertensive therapy at the time of study entry.
Severe vascular disease including tortuosity and/or occlusive disease that would preclude the safe introduction of a guiding catheter/sheath, cerebral protection device, balloon catheter, stent delivery system or stent placement. Severe tortuosity is defined as 2 or more >90 degree bend points within 3cm of the target stenosis. One of these bends will be considered to be present if the ICA branches from the CCA at a 90 degree angle. This includes aortic arch anatomy that is unacceptable for carotid stent placement.
Intraluminal filling defect thought to represent thrombus.
Excessive calcification: defined as fluoroscopic evidence of calcium that extends circumferentially around the target lesion and includes the majority of the atherosclerotic plaque.
Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) prior to stent placement.
Significant (> 60%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off.
Presence of a previously placed intravascular stent in the ipsilateral carotid distribution.
Cerebral aneurysm (symptomatic or > 10 mm) or arteriovenous malformation (AVM) of the cerebral vasculature.
Bilateral carotid stenosis (ICA/CCA contralateral stenosis > 60% by ultrasound or angiography).

Trial locations and contacts

62 sites in 1 country.

City, postcode or hospital

62 sites in 1 country

United States62 sites

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

Other trials in United States

About this study

Read the 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.

Conditions: Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis
Being tested: Carotid artery stenting with filter (interventional), Carotid artery endarterectomy (surgical)
Keywords: Carotid stenting, Carotid endarterectomy, Carotid artery disease with severe narrowing of the artery, Stroke prevention
Medical subject headings: Carotid Artery Diseases, Carotid Stenosis, Stroke, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carotid artery stenting with filter (interventional)Device
Carotid artery stenting with filter (interventional)
Carotid artery endarterectomy (surgical)Procedure or surgery
Carotid artery endarterectomy (surgical)

Study groups in NCT00106938
Study group	Role	What they receive
1	Active comparator	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. Receives: Device: Carotid artery stenting with filter (interventional)
2	Active comparator	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. Receives: Procedure: Carotid artery endarterectomy (surgical)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0 to 365 days

Secondary outcomes (32)

Acute Device Success: Xact Carotid Stent
Defined as attainment of final residual diameter stenosis of < 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.
Measured: On day 0 after index procedure
Acute Device Success: Embolic Protection Device System
Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.
Measured: On day 0 after index procedure
Procedural Success
Procedural success is defined as the attainment of target lesion final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.
Measured: 0 to 30 days post procedure
Composite Morbidity Measure
A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.
Measured: 0 to 30 Days Post-procedure
Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)
Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Measured: 0 to 180 days
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Measured: 0 to 365 days
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Measured: 0 to 730 days
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Measured: 0 to 1095 days
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Measured: 0 to 1460 days
Freedom From Clinically Indicated Target Lesion Revascularization
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
Measured: 0 to 1825 days
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Measured: 31 to 365 days
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Measured: 31 to 730 days
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Measured: 31 to 1095 days
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Measured: 31 to 1460 days
Freedom From Ipsilateral Stroke
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
Measured: 31 to 1825 days
Freedom From Mortality
Measured: 0 to 365 days
Freedom From Mortality
Measured: 0 to 730 days
Freedom From Mortality
Measured: 0 to 1095 days
Freedom From Mortality
Measured: 0 to 1460 days
Freedom From Mortality
Measured: 0 to 1825 days
Freedom From All Stroke
Measured: 0 to 365 days
Freedom From All Stroke
Measured: 0 to 730 days
Freedom From All Stroke
Measured: 0 to 1095 days
Freedom From All Stroke
Measured: 0 to 1460 days
Freedom From All Stroke
Measured: 0 to 1825 days
Death (Non-Hierarchical)
Measured: ≤ 30 Days Post Index Procedure
All Stroke (Non-Hierarchical)
Measured: ≤ 30 Days Post Index Procedure
Myocardial Infarction (MI) (Non-Hierarchical)
Measured: ≤ 30 Days Post Index Procedure
Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
Measured: ≤ 30 Days Post Index Procedure
Death or Stroke (Hierarchical)
Measured: ≤ 30 Days Post Index Procedure
Death or Major Stroke (Hierarchical)
Measured: ≤ 30 Days Post Index Procedure
Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years
Measured: 0 to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2005Mar 2013

First posted4 Apr 2005 (estimated)
Study startApr 2005
Primary completionMar 2013
Study completionMar 2013

Why it stopped: Business decision and not a result of any patient or product safety issues.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,663 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00106938
Sponsor's protocol ID: AVD-640-0052
Acronym: ACT I
Status last verified: Jun 2017
First submitted: 1 Apr 2005
Last updated: 19 Jul 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 28982691
Rosenfield 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.
PubMed 26886419

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
Hypertension, Hypertension (HTN)

All Carotid Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00106938
Acronym / sponsor ID: ACT I / AVD-640-0052
Conditions: Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis
Keywords: Carotid stenting, Carotid endarterectomy, Carotid artery disease with severe narrowing of the artery, Stroke prevention
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision and not a result of any patient or product safety issues.
Enrolment: 1,663 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 4 Apr 2005 (estimated)
Results: Posted 21 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Device: Carotid artery stenting with filter (interventional)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.
2	Active comparator	Procedure: Carotid artery endarterectomy (surgical)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.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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).

Key exclusion criteria (44 listed)

Each potential subject must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Carotid artery stenting with filter (interventional)Carotid artery stenting with filter (interventional)	Device	1
Carotid artery endarterectomy (surgical)Carotid artery endarterectomy (surgical)	Procedure or surgery	2

Primary outcome

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.
Time frame: 0 to 365 days

32 secondary outcomes

Acute Device Success: Xact Carotid Stent
Time frame: On day 0 after index procedure
Acute Device Success: Embolic Protection Device System
Time frame: On day 0 after index procedure
Procedural Success
Time frame: 0 to 30 days post procedure
Composite Morbidity Measure
Time frame: 0 to 30 Days Post-procedure
Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)
Time frame: 0 to 180 days
Freedom From Clinically Indicated Target Lesion Revascularization
Time frame: 0 to 365 days
Freedom From Clinically Indicated Target Lesion Revascularization
Time frame: 0 to 730 days
Freedom From Clinically Indicated Target Lesion Revascularization
Time frame: 0 to 1095 days
Freedom From Clinically Indicated Target Lesion Revascularization
Time frame: 0 to 1460 days
Freedom From Clinically Indicated Target Lesion Revascularization
Time frame: 0 to 1825 days
Freedom From Ipsilateral Stroke
Time frame: 31 to 365 days
Freedom From Ipsilateral Stroke
Time frame: 31 to 730 days
Freedom From Ipsilateral Stroke
Time frame: 31 to 1095 days
Freedom From Ipsilateral Stroke
Time frame: 31 to 1460 days
Freedom From Ipsilateral Stroke
Time frame: 31 to 1825 days
Freedom From Mortality
Time frame: 0 to 365 days
Freedom From Mortality
Time frame: 0 to 730 days
Freedom From Mortality
Time frame: 0 to 1095 days
Freedom From Mortality
Time frame: 0 to 1460 days
Freedom From Mortality
Time frame: 0 to 1825 days
Freedom From All Stroke
Time frame: 0 to 365 days
Freedom From All Stroke
Time frame: 0 to 730 days
Freedom From All Stroke
Time frame: 0 to 1095 days
Freedom From All Stroke
Time frame: 0 to 1460 days
Freedom From All Stroke
Time frame: 0 to 1825 days
Death (Non-Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
All Stroke (Non-Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Myocardial Infarction (MI) (Non-Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Death or Stroke (Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Death or Major Stroke (Hierarchical)
Time frame: ≤ 30 Days Post Index Procedure
Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years
Time frame: 0 to 5 years

Results and safety

Results posted to the registry on 21 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAS Group	1,089	913
CEA Group	364	293

Primary outcome: 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.

Time frame: 0 to 365 days. Number. Unit: percentage of participants

Measure	CAS Group n = 1089	CEA Group n = 364
Value	3.8	3.4

32 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CAS Group	376 of 1,089 (34.5%)	635 of 1,089 (58.3%)	Not reported
CEA Group	118 of 364 (32.4%)	216 of 364 (59.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28982691Weinberg 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.
Derived from this study: PubMed 26886419Rosenfield 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.

Related trials for Carotid Artery Disease

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
Hypertension, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jon Matsumura, MD principal investigator

University of Wisconsin, Madison

Kenneth Rosenfield, MD principal investigator

Massachusetts General Hospital

62 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 0 to 365 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00106938, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.