Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study "ASTI"

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.

Detailed Description

According to the World Health Organization, 15 million people suffer stroke each year. Of these, 5 million die and another 5 million are permanently disabled. Predominant mechanism responsible for stroke is embolism from proximal rupture of atherosclerotic plaque and thrombus. 25-30% of stroke deaths related to the carotid stenosis. The primary therapy for carotid occlusive disease is the surgical removal of this atherosclerotic plaque from inside the artery. Another treatment option for subjects with significant surgical risk factors has been found: the carotid artery stenting is a non-surgical procedure which unblocks narrowing of the carotid artery lumen by inserting a small metal tube (stent) to keep the plaque against the wall of the artery to improve blood flow.

Conditions

Interventions

  • Carotid Artery Stenting Device
    Intervention Desc: The Adapt Carotid Stent System is intended to deliver a self-expanding Stent to the extra-cranial carotid arteries via a sheathed percutaneous Monorail delivery system. The Adapt Carotid Stent is a closed cell, self-expanding, rolled nitinol (nickel-titanium alloy) sheet. The stent is thin, flexible and expands to appose the vessel wall. The FilterWire EZ System is a temporary intravascular guide wire filtration system that is placed in the vessel distal to the lesion to be treated. It consists of either a polyurethane filter bag 1.5 cm in length or a Bionate (polycarbonate urethane) filter bag, 1.0 cm in length attached near the distal end of a 0.014" silicone coated stainless steel guide wire by means of a collapsible, self-conforming, Nitinol filter loop wire.
    ARM 1: Kind: Experimental
    Label: Adapt Carotid Stent System
    Description: Intervention with Adapt Carotid Stent System with the FilterWire EZ System

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary 30-day rate of major adverse events 30-day postprocedure Yes
Secondary Late ipsilateral stroke 31 through 365 days post procedure Yes
Secondary System Technical Success the procedure time No
Secondary Device Malfunctions from index procedure to 365 days post procedure No
Secondary Serious device-related and procedure-device related Events from index procedure to 365 days post procedure Yes
Secondary Target Lesion Revascularization from end of index procedure to 365 days postprocedure No
Secondary In-stent Restenosis from end of index procedure to 365 days post procedure No
Secondary Major Adverse Events Rate by subgroups from index procedure to 365 days post procedure Yes

Sponsors