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)

Abbott Medical Devices62 sites in 1 country1,663 target enrollmentApril 2005

ConditionsCarotid Artery Disease Carotid Stenosis Stroke Atherosclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carotid Artery Disease
Sponsor: Abbott Medical Devices
Enrollment: 1663
Locations: 62
Primary Endpoint: 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.
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

March 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)
Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)(0 to 180 days)
Death, Stroke or Myocardial Infarction (MI) (Hierarchical)(≤ 30 Days Post Index Procedure)
Freedom From Mortality(0 to 1825 days)
Death (Non-Hierarchical)(≤ 30 Days Post Index Procedure)
Procedural Success(0 to 30 days post procedure)
Composite Morbidity Measure(0 to 30 Days Post-procedure)
Freedom From Ipsilateral Stroke(31 to 1825 days)
Freedom From All Stroke(0 to 1825 days)
Myocardial Infarction (MI) (Non-Hierarchical)(≤ 30 Days Post Index Procedure)
Death or Major Stroke (Hierarchical)(≤ 30 Days Post Index Procedure)
Freedom From Clinically Indicated Target Lesion Revascularization(0 to 1825 days)
All Stroke (Non-Hierarchical)(≤ 30 Days Post Index Procedure)
Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years(0 to 5 years)
Death or Stroke (Hierarchical)(≤ 30 Days Post Index Procedure)