A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)
NCT ID: NCT01273350
Last Updated: 2014-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
154 participants
INTERVENTIONAL
2004-10-31
2017-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
Single arm observational study looking at a "low risk" cohort of individuals with carotid stenosis
Carotid PTA and stenting
Percutaneous interventional treatment of carotid artery stenosis using XACT carotid artery stent and emboshield protection system with bivalirudin as the procedural anticoagulant
Interventions
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Carotid PTA and stenting
Percutaneous interventional treatment of carotid artery stenosis using XACT carotid artery stent and emboshield protection system with bivalirudin as the procedural anticoagulant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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/mm3.
* 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
* The patient has had an intracranial hemorrhage, hemorrhagic stroke, major stroke or any stroke within one week of index procedure
* The patient has concurrent emboligenic cardiovascular disease not adequately treated with anticoagulant therapy
* The patient is on renal dialysis
* The patient has had low molecular weight heparin (LMWH) administered within 8 hours or less, prior to the procedure
* Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry(BP\> 180/110mmHG)
* The patient is unable or unwilling to cooperate with the study follow-up procedures
18 Years
ALL
No
Sponsors
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SPSI d.b.a Capital Cardiovascular Associates
OTHER
Responsible Party
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Rajesh Dave, MD
Chief Medical Executive Holy Spirit Cardiovascular Institute
Principal Investigators
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Rajesh M Dave, MD
Role: PRINCIPAL_INVESTIGATOR
Spirit Physician Services Inc. d.b.a.Capital Cardiovascular Associates @ PinnacleHealth Hospitals; Holy Spirit Hospital
Locations
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Spirit Physycian Services Inc.d.b.a Capital Cardiovascular Associates
Camp Hill, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Rajesh M Dave, MD
Role: primary
Andreas L Wali, MD
Role: backup
Other Identifiers
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Physician IDE G # 040160
Identifier Type: -
Identifier Source: org_study_id