Status:
COMPLETED
Carotid With Bivalirudin Angioplasty
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Carotid Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Single center randomized clinical trial, to evaluate the safety and efficacy of carotid artery stenting using the RX ACCULINK™ Carotid Stent System with RX ACCUNET™ Embolic Protection System or PercuS...
Eligibility Criteria
Inclusion
- The patient must be at least 18 years of age.
- 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
- The patient has had a recent (\<4 weeks) disabling stroke or dementia with major neurologic deficit (stroke scales: Barthel \<60, NIH \>15, or Rankin \>3) at pre-procedure neuro exam.
- 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.
- Angiographic Exclusion Criteria
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT00812383
Start Date
August 1 2003
End Date
December 1 2019
Last Update
October 28 2020
Active Locations (1)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010