Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)

Completed · Not applicable

Conditions studied: Carotid Artery Disease

In brief

The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease in high-surgical risk subjects.

Key facts

Study ID

NCT00402740

Run by

Abbott Medical Devices

People needed

322

Starts

2006-11-01

Expected to finish

2011-10-01

Last updated by the study team

2012-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• The subject is participating in another investigational trial that would interfere with the conduct or result of this study.
• The subject has dementia or a neurological illness that may confound the neurological evaluation.
• Total occlusion of the target vessel.
• There is an existing, previously placed stent in the target artery.
• The subject has a known life-threatening allergy to the contrast media that cannot be treated.
• Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and Clopidogrel or aspirin and Ticlopidine.
• The subject has a GI bleed that would interfere with antiplatelet therapy.
• The subject has known cardiac sources of emboli, including but not limited to current or past history of paroxysmal or sustained atrial fibrillation (treated or untreated), valve replacement, etc.
• Subject has Hemoglobin (Hgb) less than 8 gm/dL (unless on dialysis), platelet count <50,000/mm3, or known heparin associated thrombocytopenia.
• The subject has a history of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin or Bivalirudin (Angiomax™) in amounts sufficient to maintain an ACT of >250, or will refuse blood transfusion.
• The subject has atherosclerotic disease involving adjoining vessels that precludes safe placement of the guiding catheter or sheath.
• The subject has other abnormal angiographic findings that indicate the subject is at risk for a stroke due to a problem other than that of the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.
• There is evidence of a carotid artery dissection prior to the initiation of the index procedure.
• There is an angiographically visible thrombus.
• There is any condition that precludes proper angiographic assessment, placement of the cerebral protective system or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure >180 mm Hg, tortuosity, occlusive disease, vessel anatomy, or aortic arch anatomy.
• Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
• There is evidence of bilateral carotid stenosis that would require intervention within 30 days of the index procedure.
• There is evidence of a stroke within the previous 30 days of the index procedure.
• There is a planned treatment of a non-target lesion within 30 days post-index procedure.
• There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke.
• There is a history of an ipsilateral stroke with fluctuating neurologic symptoms within one year of the index procedure.

Where it is running

• Washington Hospital — Fremont, California, United States
• El Camino Hospital — Mountain View, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Memorial Hospital Jacksonville — Jacksonville, Florida, United States
• Lakeland Regional Medical Center — Lakeland, Florida, United States
• Munroe Regional Medical Center — Ocala, Florida, United States
• Hawaii Permanente Medical Group-Kaiser Foundation Hospital — Honolulu, Hawaii, United States
• Northwestern University Memorial Hospital — Chicago, Illinois, United States
• St. John's Hospital / Memorial Medical Center — Springfield, Illinois, United States
• Parkview Hospital — Fort Wayne, Indiana, United States
• St. Vincent Hospital and Health Care Center — Indianapolis, Indiana, United States
• Terrebonne General Medical Center — Houma, Louisiana, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• McLaren Regional Medical Center — Flint, Michigan, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Our Lady of Lourdes Medical Center — Camden, New Jersey, United States
• St. Michael's Medical Center — Newark, New Jersey, United States
• Millard Fillmore Hospital-Kaleida Health Systems — Buffalo, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• WakeMed Hospital — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.