Carotid With Bivalirudin Angioplasty (COBRA)
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ClinicalTrials.gov Identifier: NCT00812383 |
Recruitment Status
:
Completed
First Posted
: December 22, 2008
Last Update Posted
: November 1, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carotid Artery Disease | Device: RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 299 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Carotid With Bivalirudin Angioplasty |
Study Start Date : | August 2003 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

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
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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
|
- To evaluate clinical success (<50% residual stenosis at all treatment sites without death, myocardial infarction, stroke or major bleed) [ Time Frame: 30 days ]
- To assess for complications including death, myocardial infarction, major or minor stroke, major or minor bleeding, and vascular complications. [ Time Frame: In hospital and 30 days ]
- To assess stent patency , and occurence of death or recurrent neurological events [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812383
United States, District of Columbia | |
Washington Hospital Center | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | Lowell Satler, MD | Medstar Washington Hospital Center |
Responsible Party: | Medstar Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00812383 History of Changes |
Other Study ID Numbers: |
COBRA |
First Posted: | December 22, 2008 Key Record Dates |
Last Update Posted: | November 1, 2013 |
Last Verified: | October 2013 |
Additional relevant MeSH terms:
Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Bivalirudin Hirudins |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents |