Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study (ASTI)
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.
Carotid Artery Disease
Device: Carotid Artery Stenting
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study|
- 30-day rate of major adverse events [ Time Frame: 30-day postprocedure ] [ Designated as safety issue: Yes ]30-day rate of major adverse events, defined as the cumulative incidence of any peri-procedural (less or equal to 30 days postprocedure) death, stroke, or Myocardial Infarction
- Late ipsilateral stroke [ Time Frame: 31 through 365 days post procedure ] [ Designated as safety issue: Yes ]
- System Technical Success [ Time Frame: the procedure time ] [ Designated as safety issue: No ]successful placement and retireval of the FilterWire EZ System, and the successful deployment of the Adapt Carotid Stent sytem in the target carotid artery, with a residual stenosis < or equal to 30% as determined by the core lab.
- Device Malfunctions [ Time Frame: from index procedure to 365 days post procedure ] [ Designated as safety issue: No ]Define as any failure of the device to meet performance specifications or otherwise perform as intended, as defined by the investigator.
- Serious device-related and procedure-device related Events [ Time Frame: from index procedure to 365 days post procedure ] [ Designated as safety issue: Yes ]
- Target Lesion Revascularization [ Time Frame: from end of index procedure to 365 days postprocedure ] [ Designated as safety issue: No ]any surgical or percutaneous attempt to revascularize the target lesion after the initial or index treatment when the diameter restenosis is either equal to 50% or above with symptoms related to the target lesion or 80% or above without symptoms related to the target lesion.
- In-stent Restenosis [ Time Frame: from end of index procedure to 365 days post procedure ] [ Designated as safety issue: No ]
- Major Adverse Events Rate by subgroups [ Time Frame: from index procedure to 365 days post procedure ] [ Designated as safety issue: Yes ]
Major Adverse Events Rate by subgroups
- symptomatic and asymptomatic status
- per center
|Study Start Date:||June 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Adapt Carotid Stent System
Intervention with Adapt Carotid Stent System with the FilterWire EZ System
Device: Carotid Artery Stenting
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.
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.
|A.Z. Sint Blasius|
|Dendermonde, East-Flanders, Belgium, 9200|
|Bonheiden, Belgium, B-9200|
|CHU Sart Tilman|
|Liege, Belgium, B-400|
|Königin Elisabeth Herzberge|
|Berlin, Germany, D-10365|
|Dortmund, Germany, D-44137|
|Heidelberg, Germany, D69120|
|Leipzig, Germany, D-04289|
|Klinikum Neuperlach Munich|
|Munich, Germany, D-81737|
|Tübingen, Germany, D-72076|
|Hospital Juan Canalejo|
|La Coruna, Spain, 15174|
|Complejo Hospitalario de Toledo|
|Toledo, Spain, S-45004|
|Principal Investigator:||Marc Bosiers, MD|
|Study Director:||Monika Hanisch, PhD||Boston Scientific Corporation|