A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With A… (NCT01273350) | Clinical Trial Compass
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A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)
United States154 participantsStarted 2004-10
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/mm3.
* Stroke within 7 days prior to …
What they're measuring
1
Major adverse events, defined as death, ipsilateral stroke, myocardial infarction,(Q and non-Q wave) or major bleeding as 30 days post procedure
Timeframe: 30 days
Trial details
NCT IDNCT01273350
SponsorSPSI d.b.a Capital Cardiovascular Associates