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
  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:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1663
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: April 2, 2014
Last Updated: October 13, 2014
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:
Carotid Artery Diseases
Carotid Stenosis
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014