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

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:

MedlinePlus related topics: Atherosclerosis Carotid Artery Disease

U.S. FDA Resources

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

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

Show 62 Study Locations

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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:

Atherosclerosis
Carotid Artery Diseases
Carotid Stenosis
Stroke
Cerebral Infarction
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 16, 2013