Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™

Boston Scientific Corporation19 sites in 3 countries488 target enrollmentDecember 2001

ConditionsTransient Ischemic Attack Thromboembolic Stroke Stroke Prevention

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Transient Ischemic Attack
Sponsor: Boston Scientific Corporation
Enrollment: 488
Locations: 19
Primary Endpoint: Major clinical events at one-year defined as any death, stroke or myocardial infarction
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to demonstrate the safety of the NexStent for treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire distal embolic protection device. The rates will be compared to an Objective Performance Criterion (OPC) derived from historic data from high-risk patients undergoing surgical intervention with Carotid endarterectomy. Patients included in this study are those at higher risk for complications associated with CEA.

Registry

clinicaltrials.gov

Start Date

December 2001

End Date

June 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Eligibility Criteria

Inclusion Criteria

•patient is greater than or equal to 18 years of age.
•Anticipated patient life expectancy is of at least one year from the date of the index procedure.
•Lesion is located in the common carotid artery (CCA) and/or the internal carotid artery (ICA) or the carotid bifurcation.
•Target vessel is the only vessel being treated at this intervention and the lesion is less than or equal to 30 mm and can be treated with a single stent.
•Vessel to be treated is between 4.0 mm and 9.0 mm in diameter.
•Patient can be either symptomatic or asymptomatic; Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke, TIA and/or amaurosis fugax in the hemisphere supplied by the target vessel within 180 days of the procedure.
•Patient can be either symptomatic or asymptomatic; Asymptomatic: Stenosis must be greater than or equal to 60% as determined by angiogram without any neurological symptoms.
•Distal vessel "landing zone" for placement of the FilterWire must be between 3.5 mm and 5.5 mm in diameter with visual angiographic recommendations as described in the IFU.
•Female patients with no childbearing potential or a documented negative pregnancy test (urine or blood) within 10 days of the index procedure.
•Patient (or their legal guardian) understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.

Exclusion Criteria

•Previously placed stent in target vessel.
•Total occlusion of target vessel (ICA or CCA).
•Angiographically visible thrombus.
•Carotid string sign (a tiny, long segment of contrast in the true lumen of the artery, aneurysmal pouch formation, and the distal location of the arteriopathy) with poor visualization of the distal vessel.
•Vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the targeted carotid artery.
•Vessel anatomy precluding use of stent system or distal protection system.
•Presence of carotid artery dissection.
•Requirement for staged CABG, valve replacement or abdominal aortic aneurysm procedure 30 days before or after the index procedure.
•Evidence of a major disabling stroke within the previous 30 days.
•Patient has an evolving stroke or has experienced a major stroke (NIHSS score greater than or equal to 15) within 3 months.

Outcomes

Primary Outcomes

Major clinical events at one-year defined as any death, stroke or myocardial infarction

Time Frame: 1 year

30-day event rate defined as any death, stroke or myocardial infarction less than or equal to 30-days post-procedure; plus the 31-day to 12-month event rate defined as any ipsilateral stroke including any death as a result of an ipsilateral stroke.

Time Frame: 1 year