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

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2012

Conditions
Carotid Artery DiseaseCarotid StenosisStroke
Interventions
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."

Trial Locations (11)

9200

A.Z. Sint Blasius, Dendermonde

15174

Hospital Juan Canalejo, A Coruña

B-9200

Imelda Ziekenhuis, Bonheiden

B-400

CHU Sart Tilman, Liège

D-10365

Königin Elisabeth Herzberge, Berlin

D-44137

Klinikum Dortmund, Dortmund

D69120

Universitaetsklinikum Heidelberg, Heidelberg

D-04289

Park KH, Leipzig

D-81737

Klinikum Neuperlach Munich, Munich

D-72076

Radiologische Universitätklinik, Tübingen

S-45004

Complejo Hospitalario de Toledo, Toledo

All Listed Sponsors
collaborator

CRO genae

UNKNOWN

collaborator

Massachusetts General Hospital

OTHER

collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

Medidata Solutions

INDUSTRY

lead

Boston Scientific Corporation

INDUSTRY