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
  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:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1665
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
Last Updated: April 4, 2013
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 Stenosis
Carotid Artery Diseases
Stroke
Cerebral Infarction
Atherosclerosis
Arteriosclerosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on October 19, 2014