In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Heart / Stent
Title
A Carotid Stenting registry for Wallstent (Heart / Stent)
Description
This is a data collection study for patients being treated with the Carotid WALLSTENT Monorail Endoprosthesis and FilterWire EZ for narrowing of the carotid artery that will be treated with a stent procedure. These devices are FDA approved for use in these patients.
IRB Number
Pro1054
Inclusion/Notes
INCLUSION:
Subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of same side or bilateral carotid artery disease and meets the criteria outlined below:
a. Subject with neurological symptoms and >/=50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, OR
b. Subjects without neurological symptoms and >/=80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram.
Subject has a reference vessel diameter >/=4.0 mm and /=3.5 mm and 3. Subject is willing and able to comply with all follow-up requirements.
Subject has provided a signed informed consent prior to participation in the Registry.
EXCLUSION:
Subjects in whom anticoagulant and/or antiplatelet therapy is contraindicated.
Subjects with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system.
Subjects with uncorrected bleeding disorders.
Lesions in the opening of the common carotid artery.
