Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™ "CABERNET"

Completed

Phase 3 Results

Trial Description

The primary objective of this study is to demonstrate the safety of the NexStent for treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire distal embolic protection device. The rates will be compared to an Objective Performance Criterion (OPC) derived from historic data from high-risk patients undergoing surgical intervention with Carotid endarterectomy. Patients included in this study are those at higher risk for complications associated with CEA.

Conditions

Interventions

  • NexStent Carotid Stent System Other
    Intervention Desc: Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
  • FilterWire EZ Other
    Intervention Desc: Used as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid artery and bypass grafts.
  • EndoTex™ NexStent™ Device
    Intervention Desc: EndoTex™ NexStent™ is a flexible, fine mesh Nitinol stent used to treat patients that are at high risk of adverse events from carotid endarterectomy and require carotid revascularization of a target vessel that has a reference diameter between 4mm and 9mm and stenosis that is less than 30mm in length.
    ARM 1: Kind: Experimental
    Label: 1
  • Filter Wire EZ™ Device
    Intervention Desc: EPI Fliter Wire EZ™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
    ARM 1: Kind: Experimental
    Label: 1

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Single Group Assignment

Patient Involvement

Patient with carotid artery lesions in need of treatment with stenting and at higher risk for complications associated with CEA will have surgery using the NexStent and Filter Wire EZ system.

Outcomes

Type Measure Time Frame Safety Issue
Primary Major clinical events at one-year defined as any death, stroke or myocardial infarction; 30-day event rate defined as any death, stroke or myocardial infarction less than or equal to 30-days post-procedure; plus the 31-day to 12-month event rate defined as any ipsilateral stroke including any death as a result of an ipsilateral stroke.
Secondary NexStent™ technical success; FilterWire EZ™ technical success; overall system technical success; angiographic success; procedure success; restenosis; target vessel revascularization.
Primary Major clinical events at one-year defined as any death, stroke or myocardial infarction 1 year Yes
Primary 30-day event rate defined as any death, stroke or myocardial infarction less than or equal to 30-days post-procedure; plus the 31-day to 12-month event rate defined as any ipsilateral stroke including any death as a result of an ipsilateral stroke. 1 year Yes
Secondary NexStent™ technical success post surgery Yes
Secondary FilterWire EZ™ technical success post surgery Yes
Secondary Overall system technical success post surgery Yes
Secondary Angiographic success post procedure Yes
Secondary Procedure Success 24 hours post procedure Yes
Secondary Restenosis 1 year Yes
Secondary Target vessel revascularization 1 year Yes

Sponsors