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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COMPLETED
PHASE2
299 participants
INTERVENTIONAL
2003-08-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bivalirudin
RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System
Angiomax (bivalirudin) versus standard anticoagulation with heparin during carotid artery stenting with distal protection clinical endpoint evaluation
Heparin
RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System
Angiomax (bivalirudin) versus standard anticoagulation with heparin during carotid artery stenting with distal protection clinical endpoint evaluation
Interventions
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RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System
Angiomax (bivalirudin) versus standard anticoagulation with heparin during carotid artery stenting with distal protection clinical endpoint evaluation
Eligibility Criteria
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Inclusion Criteria
* The patient must have a significant diameter reduction of the extracranial or intracranial internal or common carotid artery, defined as ≥50% stenosis for symptomatic patients or ≥80% stenosis for asymptomatic patients determined by carotid duplex ultrasound scan and/or carotid angiography.
* Female patients with child bearing potential must have a negative pregnancy test.
* The patient and the patient's physician must agree to have the patient return for a 30-day and one-year clinical and ultrasound imaging follow-up evaluations as indicated in the protocol.
* Reference vessel diameter ≥ 3.5 mm - ≤ 9.0 mm diameter.
Exclusion Criteria
* The patient has had within four weeks of the treatment procedure an intracranial hemorrhage, hemorrhage stroke, major stroke, or any stroke with mass effect demonstrated on MRI or CT.
* The patient has a known allergy to heparin, bivalirudin, aspirin or to anti-platelet agents that prevents taking aspirin plus ticlopidine or aspirin plus clopidogrel.
* The patient has received fractionated or unfractionated heparin within 8 hours prior to the procedure.
* The patient has a history of prior life-threatening radiocontrast reaction that cannot be pre-treated.
* The patient has a history of bleeding diathesis or coagulopathy within 3 months.
* The patient is currently participating in another study protocol that may influence either procedure results or follow-up evaluations.
* Plasma/serum creatinine \> 3.0 mg/dl at time of intervention.
* Hemodynamic instability at the time of intervention.
* Previous stent placement in the ipsilateral carotid distribution.
* The patient has an intracranial tumor, or cerebral arterio-venous malformation(s) \> 5mm, aneurysms or severe intracranial stenosis distal to target lesion.
* The patient has inaccessible intracranial arterial stenosis greater in severity than the extracranial internal carotid artery lesion.
* There is angiographic evidence of significant intra-luminal thrombus burden with presumed increased risk of plaque fragmentation and consequent distal embolization.
* There is total occlusion of the ipsilateral carotid artery treatment site with TIMI 0 flow characteristics.
* The reference segment diameter (internal carotid artery segment cephalad to the lesion) is less than 3 millimeters by operator visual estimate.
* The patient has peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding use of catheter-based techniques required for successful CSSA
18 Years
ALL
No
Sponsors
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Medstar Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Lowell Satler, MD
Role: PRINCIPAL_INVESTIGATOR
Medstar Health Research Institute
Locations
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Washington Hospital Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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COBRA
Identifier Type: -
Identifier Source: org_study_id