Carotid Artery Stent Trial

Stenting And Angioplasty With Protection In Patients At High Risk For Endarterectomy (SAPPHIRE WW Post Marketing Registry).

This is a multicenter, prospective, observational study to assess the 30 day and 360 day major adverse event (death, stroke, or MI) rate of carotid stenting with cerebral emboli protection in high-surgical risk patients. The study uses the FDA approved Cordis Carotid Stent System.

The purpose of the study is to further evaluate the potential association or incidence of death, stroke, or heart attack in patients whose significant carotid artery disease is treated with carotid artery stenting, rather than surgery, because their other medical problems put them at very high risk for stroke heart attack or death with the standard surgical treatment.

We are one of only 351 centers in the United States chosen to participate in the study. Our results are far superior to those reported in other carotid stent studies with a post procedure stroke rate of less than 3% for patients enrolled at our site.

Enrollment criteria:
Patients with the following characteristics may qualify for participation in this study:
(Must have one of the following)

  1. Symptoms of loss of vision in one eye (amaurosis), mini strokes (TIA), or stroke attributable to a carotid artery narrowing of 50% or more.
  2. Patients with an 80% or greater carotid artery narrowing and no symptoms.

(Must also have one of the following high risk criteria)

  • Age greater than 75 years
  • Congestive heart failure (class III/IV)
  • Left heart dysfunction (ejection fraction less than 35%)
  • Abnormal cardiac stress test
  • Coronary artery disease which is non-reconstructable
  • Open heart surgery within 6 weeks
  • Unstable angina (class III/IV)
  • In need of cardiac valve surgery, peripheral vascular surgery, or abdominal aortic aneurysm repair within 60 days
  • Severe lung disease
  • Carotid occlusion on the opposite side
  • Radiation to the neck
  • Recurrent carotid artery narrowing after previous carotid artery surgery
  • Carotid artery with more than one narrowing in it
  • Carotid artery narrowing that is either high in the neck or low in the chest
  • Dialysis dependent renal failure
  • On a list for major organ transplant
  • Tracheostomy
  • Spinal immobility with poor neck movement

If you meet the criteria listed above, please call to make an appointment so we can further assess whether or not you may qualify for this study.

Mark Ombrellaro, MD
Principle Investigator, Sapphire WW

Allen Rubin, MD
Sub Investigator

Omar Dorzi, MD
Sub Investigator

Jennifer Allar
Study Coordinator

Study Site: Bellevue, Washington (Overlake Hospital)