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A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)

Carotid Stenosis Clinical Trial

Official title:
Physician I.D.E. G#040160; Low Risk Carotid Stenting Study Using Bivalirudin at PinnacleHealth Hospitals and Holy Spirit Hospital

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01273350
Study type Interventional
Source SPSI d.b.a Capital Cardiovascular Associates
Contact Rajesh M Dave, MD
Phone 717-724-6450
Email rdintervention@yahoo.com
Status Recruiting
Phase N/A
Start date October 2004
Completion date December 2017
View Details
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