Carotid Artery Disease
Conditions
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.
Interventions
DEVICERX 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
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate clinical success (<50% residual stenosis at all treatment sites without death, myocardial infarction, stroke or major bleed) | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed