Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT01273350
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/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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01273350
Study Brief:
Protocol Section:
NCT01273350