View Clinical Trial (Medical Research Study)
Physician I.D.E. G#040160; Low Risk Carotid Stenting Study Using Bivalirudin at PinnacleHealth Hospitals
| City: |
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Harrisburg |
| State: |
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Pennsylvania |
| Zip Code: |
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17110 |
| Conditions: |
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Carotid Stenosis |
| Purpose: |
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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
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| Study Summary: |
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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
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| Criteria: |
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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
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| NCT ID: |
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NCT01273350 |
| Primary Contact: |
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Principal Investigator
Rajesh M Dave, MD
Associated Cardiologists, PC/CPCRI , PinnacleHealth Hospitals
Rajesh M Dave, MD
Phone: 717-920-4400
Email: rdintervention@yahoo.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Harrisburg, Pennsylvania 17110
United States
Kenneth J May, MD
Phone: 717-920-4400
Email: kmay@ac-pc.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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