Prospective, non-randomized, single-center cohort study treating internal carotid artery stenosis using the Xact Carotid Artery Stent and emboshield distal protection system in conjunction with bivalirudin as the procedural anticoagulation
Primary objective is to evaluate the safety and feasibility of the XACT stent and emboshield with Angiomax as the procedural anticoagulant. Primary safety endpoint is the occurrence of Major Adverse Events, defined as death, myocardial infarction (Q or non Q wave), and from target revascularization at one year
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Percutaneous interventional treatment of carotid artery stenosis using XACT carotid artery stent and emboshield protection system with bivalirudin as the procedural anticoagulant
Spirit Physycian Services Inc.d.b.a Capital Cardiovascular Associates
Camp Hill, Pennsylvania, United States
RECRUITINGMajor adverse events, defined as death, ipsilateral stroke, myocardial infarction,(Q and non-Q wave) or major bleeding as 30 days post procedure
Time frame: 30 days
Freedom from vascular complications ;Acute success defined by lesion, device, and procedural success; Freedom from any death, stroke MI (Q, non-Q wave), and from target lesion revascularization at one year
Time frame: 1 Year
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