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) "ACT I"

Terminated

Phase 3 Results

Trial Description

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.

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.

Trial Stopped: Business decision and not a result of any patient or product safety issues.

Conditions

Interventions

  • Endarterectomy, carotid (CEA)Procedure/Surgery
    Intervention Desc: Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
  • Carotid artery stenting with filter (Emboshield Embolic Protection System and Emboshield Pro Embotic Protection System with Xact Carotid Stent System)Other
    Intervention Desc: Indicated for use as a guidewire and embolic protection system to contain and remove embolic material while performing angioplasty and stenting procedures in carotid arteries.
  • Carotid artery stenting with filter (interventional) Device
    Intervention Desc: Carotid artery stenting with filter (interventional)
    ARM 1: Kind: Experimental
    Label: 1
    Description: 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.
  • Carotid artery endarterectomy (surgical) Procedure
    Intervention Desc: Carotid artery endarterectomy (surgical)
    ARM 1: Kind: Experimental
    Label: 2
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Occurrence of major adverse events 30 days following the procedure; occurrence of ipsilateral strokes between 31 and 365 days post procedure.
Secondary Acute device success; procedural success; composite morbidity at 0 - 30 days post-procedure.
Primary Occurrence of major adverse events 30 days following the procedure Acute to 30 days Yes
Primary Occurrence of ipsilateral strokes between 31 and 365 days post procedure 31 through 365 days post procedure Yes
Secondary Acute device success Acute Yes
Secondary Procedural success Acute No
Secondary Composite morbidity at 0 - 30 days Post-Procedure 0 to 30 days post procedure Yes
Secondary Composite Morbidity Measure 0 to 30 Days Post-procedure Yes
Secondary Freedom from clinically indicated target lesion revascularization at 6 months Yes
Secondary Freedom from ipsilateral stroke at 2 years Yes
Secondary Freedom from mortality at 1 year Yes
Primary Composite of Any Death, Stroke, and Myocardial Infarction (MI) Within 30 Days Post-index Procedure 0 to 30 days Yes
Primary Composite of Any Death, Stroke, and MI Within 30 Days and Ipsilateral Stroke 31 Days to 365 Days 0 to 365 days Yes
Secondary Acute Device Success: Xact Stent 0 to 30 days post procedure Yes
Secondary Acute Device Success: Embolic Protection Device System 0 to 30 days post procedure Yes

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