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

Sponsor:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00106938

Purpose

The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System and Emboshield® Pro 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 III

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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: Carotid Artery Disease Surgery

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: Acute to 30 days ] [ Designated as safety issue: Yes ]
Occurrence of ipsilateral strokes between 31 and 365 days post procedure [ Time Frame: 31 through 365 days post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Acute device success [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
Procedural success [ Time Frame: Acute ] [ Designated as safety issue: No ]
Composite morbidity at 0 - 30 days Post-Procedure [ Time Frame: 0 to 30 days post procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1658
Study Start Date:	April 2005
Estimated Study Completion Date:	May 2018
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). A lead-in phase of up to 400 carotid stent subjects will provide investigators experience with the study devices prior to pivotal enrollment. 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)
2: Active Comparator CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA). A lead-in phase of up to 400 carotid stent subjects will provide investigators experience with the study devices prior to pivotal enrollment. 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:

Patients will be randomized to either an interventional treatment using a carotid artery stent and filter or the surgical procedure of carotid endarterectomy, on a 3:1 basis. This means that three interventional procedures will be conducted to each surgical (CEA) one, on average, for every four patients.

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

Contacts

Contact: Sandy Lee

408-845-0516

Sandy.Lee@av.abbott.com

Show 54 Study Locations

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:	Jon Matsumura, MD	Northwestern Memorial Hospital
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 ( Matt Kiely )
Study ID Numbers:	AVD-640-0052
Study First Received:	April 1, 2005
Last Updated:	September 15, 2009
ClinicalTrials.gov Identifier:	NCT00106938 History of Changes
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
Arterial Occlusive Diseases
Cerebral Infarction
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Arteriosclerosis

Brain Diseases
Cerebrovascular Disorders
Carotid Stenosis
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Carotid Artery Diseases

ClinicalTrials.gov processed this record on February 08, 2010