COBRA: Carotid With Bivalirudin Angioplasty
Study Details
Study Description
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 PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System using Angiomax (bivalirudin)versus heparin as the anticoagulant for treatment of occlusive carotid artery disease in low and high risk patient cohorts.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bivalirudin
|
Device: 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
|
| Active Comparator: Heparin
|
Device: 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
|
Outcome Measures
Primary Outcome Measures
- To evaluate clinical success (<50% residual stenosis at all treatment sites without death, myocardial infarction, stroke or major bleed) [30 days]
Secondary Outcome Measures
- To assess for complications including death, myocardial infarction, major or minor stroke, major or minor bleeding, and vascular complications. [In hospital and 30 days]
- To assess stent patency , and occurence of death or recurrent neurological events [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patient must be at least 18 years of age.
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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.
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Female patients with child bearing potential must have a negative pregnancy test.
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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.
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Reference vessel diameter ≥ 3.5 mm - ≤ 9.0 mm diameter.
Exclusion Criteria:
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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.
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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.
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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.
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The patient has received fractionated or unfractionated heparin within 8 hours prior to the procedure.
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The patient has a history of prior life-threatening radiocontrast reaction that cannot be pre-treated.
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The patient has a history of bleeding diathesis or coagulopathy within 3 months.
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The patient is currently participating in another study protocol that may influence either procedure results or follow-up evaluations.
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Plasma/serum creatinine > 3.0 mg/dl at time of intervention.
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Hemodynamic instability at the time of intervention.
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Previous stent placement in the ipsilateral carotid distribution.
Angiographic Exclusion Criteria
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The patient has an intracranial tumor, or cerebral arterio-venous malformation(s) > 5mm, aneurysms or severe intracranial stenosis distal to target lesion.
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The patient has inaccessible intracranial arterial stenosis greater in severity than the extracranial internal carotid artery lesion.
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There is angiographic evidence of significant intra-luminal thrombus burden with presumed increased risk of plaque fragmentation and consequent distal embolization.
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There is total occlusion of the ipsilateral carotid artery treatment site with TIMI 0 flow characteristics.
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The reference segment diameter (internal carotid artery segment cephalad to the lesion) is less than 3 millimeters by operator visual estimate.
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The patient has peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding use of catheter-based techniques required for successful CSSA
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
Sponsors and Collaborators
- Medstar Health Research Institute
Investigators
- Principal Investigator: Lowell Satler, MD, Medstar Washington Hospital Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COBRA