In This SectionTexas Health Research & Education Institute
Disease or Condition
Heart / Stent
Carotid Angioplasty and Stenting versus Endarterectomy (Heart / Stent)
Carotid Angioplasty and Stenting versus Endarterectomy in Asymptomatic Subjects with Significant Extracranial Carotid Occlusive Disease.
The subbject must be 18 and less than 80 years of age.
Female subjects of child bearing potential must have a documented negative pregnancy test within 30 days prio to the study procedure.
Subject must be asymptomatic, defined as no stroke or TIA (hemispheric or ocular) within the last 180 days prior to the procedure. Subjects who have experienced these neurological symptoms prior to the 180 day pre-procedure window will be wilgible for enrollment. An independent study neurologist or independent study neurosurgeon must confirm the subject's nerological status.
Subjects taking warfarin may be included if their dosage is reduced befor the procedure to result in an INR of 1.5 or less. Warfarin may be restarted after the procedure.
The subject must sign a written inforemd consent prior to the procedure, using a form that is approved by the local instituional review board (IRB).
The subject must agree to reurn for all required follow-up visits.
Subject has a descrete lesion located in the internal cartoid artery (ICA); the contigous common sarotid artery (CCA) may be involved.
Carotid stenosis is equal to or greater than 70% and equal to or less than 99% by carotid ultrasound or equal to or greater than 70% an equla to or less than 99% stenosis (visual estimate) by angiography, without signifigant (less than 60% by ultrsound or angiography) ICA/CCA contralateral stenosis.
TArget ICA vessel diameter must be visually estimated to be:
a. Equal to or greater than 2.5mm and equal to or less than 7.0 for the Emboshield Pro or for the Emboshield Pro for the Emboshield NAV6
b. Equal to or greater than 2.8 mm and equal to or less than 6.2 for the Emboshield Gen 3
c. Equal to or greater than 4.0 mm and equl to or less than 9.0 mm for the Xact stent treatment segment. An untreated contralateral ICA may be used for visual estimation when a highly stenosed lesion makes mesurment of the target vessell inaccurate.
Based on the subjects anatomy, the Ivestigator should expect to successfully deliver the stent to the target lesion (absence of extreme tortuosity, ect).
De nova target lesion that can be treated with a single stent.
Subject is symptomatic and has has a stoke of exhibited TIA (hemispheric or ocular) within 180 days prior to randomization, whish has been confirmed by an independent study nerologist or independent study nero surgeon.
Subject is participation in another drug or device trial (IND or IDE) that has not completed the primary endpoint or that may potentially confound the results of this trial. Subject may be enrolled only once in this trial and may not particiapte in any other clinical trial during a 1-year period post-index procedure.