| April 1, 2005 |
| September 15, 2009 |
| April 2005 |
| May 2013 (final data collection date for primary outcome measure) |
- 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 ]
|
| Occurrence of major adverse events following the procedure |
| Complete list of historical versions of study NCT00106938 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Acute device success
- Procedural success
- Composite morbitity at 0 - 30 days Post-Procedure
|
| |
| Carotid Stenting vs. Surgery of Severe Carotid Artery Disease and Stroke Prevention in Asymptomatic Patients (ACT I) |
| 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) |
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. |
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. |
| Phase III |
| Interventional |
| Other, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Carotid Artery Disease
- Carotid Stenosis
- Stroke
- Atherosclerosis
|
- Device: Carotid artery stenting with filter (interventional)
- Procedure: Carotid artery endarterectomy (surgical)
|
- 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.
- 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.
|
| |
| |
| Recruiting |
| 1658 |
| May 2018 |
| May 2013 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 79 Years |
| No |
|
|
| United States |
| |
| NCT00106938 |
| Matt Kiely, Abbott Vascular |
| AVD-640-0052 |
| Abbott Vascular |
|
| Principal Investigator: |
Jon Matsumura, MD |
Northwestern Memorial Hospital |
|
| Principal Investigator: |
Kenneth Rosenfield, MD |
Massachusetts General Hospital |
|
|
| Abbott Vascular |
| September 2009 |
