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

This study has been terminated.
(Business decision by the sponsor and not a result of any patient or product safety issues.)
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00106938
First received: April 1, 2005
Last updated: April 4, 2013
Last verified: April 2013

April 1, 2005
April 4, 2013
April 2005
March 2013   (final data collection date for primary outcome measure)
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.
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: 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 ]
Not Provided
Not Provided
Not Provided
 
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 with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Carotid Artery Disease
  • Carotid Stenosis
  • Stroke
  • Atherosclerosis
  • Device: Carotid artery stenting with filter (interventional)
    Carotid artery stenting with filter (interventional)
  • Procedure: Carotid artery endarterectomy (surgical)
    Carotid artery endarterectomy (surgical)
  • 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.

    Intervention: Device: 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.

    Intervention: Procedure: Carotid artery endarterectomy (surgical)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1665
March 2013
March 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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00106938
AVD-640-0052
Not Provided
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: Jon Matsumura, MD University of Wisconsin, Madison
Principal Investigator: Kenneth Rosenfield, MD Massachusetts General Hospital
Abbott Vascular
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP