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)

Stopped early · Not applicable

Conditions studied: Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis

In brief

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.

Key facts

Study ID: NCT00106938
Run by: Abbott Medical Devices
People needed: 1663
Starts: 2005-04-01
Expected to finish: 2013-03-01
Last updated by the study team: 2017-07-19

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

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…

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.
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.

Where it is running

Providence Hospital-SC — Columbia, South Carolina, United States
North Central Heart Institute — Sioux Falls, South Dakota, United States
The Stern Cardiovascular Center/Methodist Germantown Hospital — Germantown, Tennessee, United States
Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States
Mercy Medical West/Turkey Creek Medical Center — Knoxville, Tennessee, United States
Westlake Medical Center/Seton Heart Institute — Austin, Texas, United States
Heart Hospital of Austin — Austin, Texas, United States
Dallas Veteran's Administration Medical Center — Dallas, Texas, United States
Presbyterian Hospital of Dallas — Dallas, Texas, United States
St. Luke's Episcopal Hospital — Houston, Texas, United States
Chesapeake General Hospital/Sentara Norfolk General Hospital — Norfolk, Virginia, United States
St. Mary's Hospital / Virginia Cardiovascular Specilists — Richmond, Virginia, United States
Deaconess Medical Center — Spokane, Washington, United States
University of Wisconsin — Madison, Wisconsin, United States
St. Luke's Medical Center - Milwaukee — Milwaukee, Wisconsin, United States
St. Luke's Hospital-Phoenix — Phoenix, Arizona, United States
Mayo Clinic — Phoenix, Arizona, United States
Fogarty Clinical Research Inc./El Camino Hospital — Mountain View, California, United States
Hoag Memorial Hospital — Newport Beach, California, United States
St. Joseph Hospital — Orange, California, United States
Kaiser Foundation Hospital-San Diego — San Diego, California, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
Baptist Cardiac and Vascular Institute — Miami, Florida, United States
Piedmont Hospital — Atlanta, Georgia, United States
St. Joseph's Medical Center/Berks Cardiologists — Wyomissing, Pennsylvania, United States

Full record on ClinicalTrials.gov

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