A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection
A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection
The primary objective of this study is to evaluate carotid artery stenting (CAS) with and
 without cerebral protection (CP) to determine if CP improves safety and effectiveness of CAS.
This study is a single center, prospective, randomized trial evaluating the safety and
 effectiveness of CAS with and without CP. The study population will be comprised of subjects
 with atherosclerotic, post endarterectomy restenotic or other obstructive lesions in native
 carotid arteries. Other carotid artery pathology not amenable to surgical repair (for example
 carotid artery dissection) will also be considered. Subjects at high risk for complications
 from standard CEA will be the target population for this study. High risk status will be
 confirmed by two physicians, one of whom is a vascular surgeon. Both symptomatic and
 asymptomatic subjects will be enrolled. This will ensure that the proportion of symptomatic
 subjects is the same in the two arms of the study. "Symptomatic" is defined in the exclusion
 criteria. The expected duration of this clinical trial is 3 years.

 In this study there are there are two arms that a subject may be randomized to:

 Group1: CAS with the use of the RX ACCUNET Group 2: CAS without the use of the RX ACCUNET
 This study has been designed to test whether the addition of CP enhances the safety and
 effectiveness of CAS.
Inclusion Criteria:

 -  To participate in this study, the subject MUST have all of the following for inclusion
 in the study:

 • The subject (male or non-pregnant female) must be > 18 years of age.

 • The subject should have a stenosis in the common or internal carotid artery of at
 least 70% determined by one of the modalities listed below.

 • The subject should be considered a relatively high risk for carotid endarterectomy.
 This determination has to be made and documented by two physicians, at least one of
 who must be a vascular surgeon acting as an investigator on this trial. High risk
 considerations should include at least one of the following:

 1. Cardiac dysfunction. NYHA class III or above, compensated or active congestive
 heart failure (CHF), incomplete coronary revascularization, ejection fraction of
 <35%, pulmonary hypertension, or recommendation of a cardiologist against open
 CEA.

 2. Pulmonary dysfunction, history of respiratory failure, severe chronic obstructive
 pulmonary Disease (COPD) on bronchodilators or recommendation of a pulmonary
 specialist against open CEA.

 3. Multi-system dysfunction, defined as any combination of medical problems in three
 distinct systems.

 4. Anatomic issues: previous CEA or neck dissection, neck irradiation, inaccessible
 lesions, neck fusion or other anatomic considerations increasing the risk of CEA.

 5. Age >80 AND symptomatic (defined below)

 6. General debilitation documented by the subject's primary physician.

 7. Increased anesthetic risk as documented by an anesthesiologist.

 -  Subjects can be either clinically symptomatic or asymptomatic (less than 80
 years of age). Symptomatic subjects will have experienced an event within
 the previous 120 days in the ipsilateral carotid artery distribution. The
 event will be classified as either 1) one or more TIAs, characterized by
 distinct focal neurologic dysfunction or monocular blindness with clearing
 of signs and symptoms within 24 hours, or 2) one or more completed strokes
 (as defined by this protocol) with persistence of symptoms or signs for more
 than 24 hours (the most recent event is used as the qualifying event).

 **Patients with major non-hemorrhagic strokes will be included if their
 clinical status has been stable for 5 days (based on an exam performed by a
 neurologist participating as a Co-Investigator in this trial).

 -  If an angiogram is performed to qualify the subject, it should be as recent
 as feasible and will not be acceptable if done > 120 days from study entry.
 Angiograms from other institutions will be acceptable.

 -  Other non-invasive qualifying imaging modalities include:

 1. Duplex ultrasound (DU) performed at UPMC Presbyterian or Shadyside hospitals.

 2. Magnetic Resonance Angiography (MRA) performed at UPMC Presbyterian or Shadyside
 hospitals.

 3. Computed Tomographic Angiography (CTA) performed at UPMC Presbyterian or
 Shadyside hospitals.

 -  The degree of stenosis from these non-invasive studies has to be confirmed
 on the pre-deployment diagnostic angiography prior to proceeding with stent
 deployment.

 -  However, if two of the non-invasive studies listed above report a stenosis
 of >70%, AND the pre-deployment angiogram reveals a 50 -70% stenosis, the
 patient will be randomized and entered into the trial as the angiogram can
 on occasion underestimate the stenosis.

 -  Female subjects of childbearing potential must have a documented
 negative pregnancy test during the index hospitalization.

 -  The subject must sign a written informed consent, prior to the
 procedure, using a form that is approved by the local Institutional
 Review Board or Medical Ethics Committee.

 -  If a patient's creatinine is 3.5 or greater, their nephrologist must
 clear them to participate in the trial.

 Exclusion Criteria:

 -  To participate in this study, the subject may NOT HAVE any of the following at
 enrollment to the study:

 -  The subject has had an intracranial hemorrhage, hemorrhagic stroke, or any stroke
 with mass effect demonstrated on CT scan or MRI within 30 days of the index
 procedure.

 -  The subject has a persisting ischemic stroke (defined as either a score > 15 on
 the NIH stroke scale, a Rankin score > 3 or a Barthel score < 60 measured within
 one week prior to study entry).

 -  The subject has an intracranial mass lesion (i.e., abscess, tumor, or other
 infection).

 -  The subject has known allergies to heparin, to both ticlopidine and clopidogrel
 or to metals used in stents.

 -  There is any visual angiographic evidence of intraluminal thrombus thought to
 increase the risk of plaque fragmentation and distal embolization.

 -  The subject has peripheral vascular, supra-aortic or internal carotid artery
 tortuosity precluding use of catheter-based techniques required for successful
 results.

 -  The subject, if female, has a positive pregnancy test.

 -  The subject has an arterio-venous malformation in the territory of the target
 carotid artery.

 -  Subjects with highly calcified lesions resistant to predilation by PTA

 -  The subject has unstable angina (defined as Class IV or at rest), evolving MI or
 recent MI (within 14 days).

 -  The subject has any condition that precludes adequate local hemostasis.

 -  Patients who are not candidates for MRI scanning (pacemaker, etc).