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

SPSI d.b.a Capital Cardiovascular Associates1 site in 1 country154 target enrollmentOctober 2004

ConditionsCarotid Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carotid Stenosis
Sponsor: SPSI d.b.a Capital Cardiovascular Associates
Enrollment: 154
Locations: 1
Primary Endpoint: Major adverse events, defined as death, ipsilateral stroke, myocardial infarction,(Q and non-Q wave) or major bleeding as 30 days post procedure
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Detailed 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

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

December 2017

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

SPSI d.b.a Capital Cardiovascular Associates

Responsible Party

Principal Investigator

Rajesh Dave, MD

Chief Medical Executive Holy Spirit Cardiovascular Institute

SPSI d.b.a Capital Cardiovascular Associates

Eligibility Criteria

Inclusion Criteria

•Patient (male or non-pregnant female)must be \> than or= 18
•Qualifying non-invasive test (ultrasound or MRA) was performed less than 60 days prior to study entry. Carotid duplex study revealed:
•Stenosis \> or = to 50% in symptomatic patients
•Stenosis \> or = to 60% in asymptomatic patients
•Target lesion may be in the common or internal carotid artery and is amenable to treatment with angioplasty and stenting
•Patients taking warfarin may be included if their dosage is reduced before the procedure to result in an INR of 1.5 or less and a Prothrombin time of 15 seconds. Warfarin may be started after the procedure.
•Female patients of childbearing potential must have a documented negative pregnancy test during index hospitalization
•Patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board or medical ethics committee

Exclusion Criteria

•(Patients will be excluded from the study if ANY of the following conditions are present)
•There is total occlusion of the target carotid artery treatment site.
•The patient has an allergy or contraindication to aspirin, ticlopidine, clopidogrel, bivalirudin, nickel, titanium, or a sensitivity to contrast media, which cannot adequately pre-medicated.
•The subject has a platlet count\< 100,000 cells/mm3 or 700,000 cells/mm3 or a WBC of \< 3,000 cells/mm
•Stroke within 7 days prior to the procedure
•NIH stroke score \> or = to 15 within 7 days prior to the procedure
•The patient has experienced a significant GI bleed within 6 months prior to study procedure
•The patient has active internal bleeding
•The patient has had major surgery or serious trauma within 6 weeks before enrollment
•The patient has excessive peripheral vascular disease that precludes safe sheath insertion

Outcomes

Primary Outcomes

Major 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

Secondary Outcomes

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(1 Year)