Clinical trial NCT00812383: Carotid With Bivalirudin Angioplasty
Official title: Carotid With Bivalirudin Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carotid Artery Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To evaluate clinical success (<50% residual stenosis at all treatment sites without death, myocardial infarction, stroke or major bleed)
timeFrame: 30 days
Secondary outcomes:
measure: To assess for complications including death, myocardial infarction, major or minor stroke, major or minor bleeding, and vascular complications.
timeFrame: In hospital and 30 days
measure: To assess stent patency , and occurence of death or recurrent neurological events
timeFrame: 12 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Lowell Satler, MD
role: PRINCIPAL_INVESTIGATOR
References: