Carotid With Bivalirudin Angioplasty (COBRA)

Study Description

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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
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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated 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
Estimated Primary Completion Date :	July 2019
Estimated Study Completion Date :	July 2019

Arms and Interventions

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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

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Primary Outcome Measures :

1. To evaluate clinical success (<50% residual stenosis at all treatment sites without death, myocardial infarction, stroke or major bleed) [ Time Frame: 30 days ]

Secondary Outcome Measures :

1. 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 ]
2. To assess stent patency , and occurence of death or recurrent neurological events [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Contacts

Contact: Lowell Satler, M.D.	202-877-5975

Locations

United States, District of Columbia
Washington Hospital Center	Recruiting
Washington, District of Columbia, United States, 20010
Contact: Lowell Satler, M.D.
Principal Investigator: Lowell Satler, M.D.

Sponsors and Collaborators

Medstar Health Research Institute

Investigators

Principal Investigator:	Lowell Satler, MD	Medstar Washington Hospital Center

More Information

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Responsible Party:	Medstar Health Research Institute
ClinicalTrials.gov Identifier:	NCT00812383 History of Changes
Other Study ID Numbers:	COBRA
First Posted:	December 22, 2008
Last Update Posted:	September 6, 2018
Last Verified:	September 2018

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