Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)

This study has been terminated.
(Business decision 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: October 13, 2014
Last verified: October 2014

April 1, 2005
October 13, 2014
April 2005
March 2013   (final data collection date for primary outcome measure)
  • Composite of Any Death, Stroke, and Myocardial Infarction (MI) Within 30 Days Post-index Procedure [ Time Frame: 0 to 30 days ] [ Designated as safety issue: Yes ]
    Major adverse events = Composite of any stroke, myocardial infarction and death during the 30-day post-procedural period.
  • Composite of Any Death, Stroke, and MI Within 30 Days and Ipsilateral Stroke 31 Days to 365 Days [ Time Frame: 0 to 365 days ] [ 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: Xact Stent [ Time Frame: 0 to 30 days post procedure ] [ Designated as safety issue: Yes ]
    Acute device success is defined as attainment of final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.
  • Acute Device Success: Embolic Protection Device System [ Time Frame: 0 to 30 days post procedure ] [ Designated as safety issue: Yes ]
    Acute device success is defined as attainment of final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.
  • Procedural Success [ Time Frame: 0 to 30 days post procedure ] [ Designated as safety issue: No ]

    Procedural success is defined as the attainment of target lesion final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.

    Angiographic data was not required for CEA arm, therefore the procedure success assessment was not available for CEA arm.

  • 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: 0 to 180 days ] [ Designated as safety issue: Yes ]
  • Freedom From Clinically Indicated Target Lesion Revascularization [ Time Frame: 0 to 365 days ] [ Designated as safety issue: Yes ]
  • Freedom From Clinically Indicated Target Lesion Revascularization [ Time Frame: 0 to 730 days ] [ Designated as safety issue: Yes ]
  • Freedom From Clinically Indicated Target Lesion Revascularization [ Time Frame: 0 to 1095 days ] [ Designated as safety issue: Yes ]
  • Freedom From Clinically Indicated Target Lesion Revascularization [ Time Frame: 0 to 1460 days ] [ Designated as safety issue: Yes ]
  • Freedom From Clinically Indicated Target Lesion Revascularization [ Time Frame: 0 to 1825 days ] [ Designated as safety issue: Yes ]
  • Freedom From Ipsilateral Stroke [ Time Frame: 31 to 365 days ] [ Designated as safety issue: Yes ]
  • Freedom From Ipsilateral Stroke [ Time Frame: 31 to 730 days ] [ Designated as safety issue: Yes ]
  • Freedom From Ipsilateral Stroke [ Time Frame: 31 to 1095 days ] [ Designated as safety issue: Yes ]
  • Freedom From Ipsilateral Stroke [ Time Frame: 31 to 1460 days ] [ Designated as safety issue: Yes ]
  • Freedom From Ipsilateral Stroke [ Time Frame: 31 to 1825 days ] [ Designated as safety issue: Yes ]
  • Freedom From Mortality [ Time Frame: 0 to 365 days ] [ Designated as safety issue: Yes ]
  • Freedom From Mortality [ Time Frame: 0 to 730 days ] [ Designated as safety issue: Yes ]
  • Freedom From Mortality [ Time Frame: 0 to 1095 days ] [ Designated as safety issue: Yes ]
  • Freedom From Mortality [ Time Frame: 0 to 1460 days ] [ Designated as safety issue: Yes ]
  • Freedom From Mortality [ Time Frame: 0 to 1825 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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)
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
1663
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
October 2014

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