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

NCT ID: NCT00402740

Last Updated: 2012-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2011-10-31

Brief Summary

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.

Conditions

Carotid Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)

All subjects will receive the Xact™ Rapid Exchange Carotid Stent System. The first 220 consecutively enrolled subjects will be treated with the investigational filter system, the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5). The remaining subjects will be treated with the FDA approved Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3).

Intervention Type: DEVICE

Other Intervention Names

Xact stent; Emboshield Pro (Gen 5); Emboshield (Gen 3)

Eligibility Criteria

Inclusion Criteria

Subject has the ability to cooperate with study procedures and agrees to return for all required follow-up visits, tests and exams.

Female subjects of childbearing potential must have a documented negative pregnancy test within 30 days prior to the index procedure.

Subjects taking warfarin may be included if their dosage is reduced before the index procedure to result in an INR of 1.5 or less. Warfarin may be restarted to therapeutic dose after the index procedure.

The subject must sign a written informed consent prior to the initiation of any study procedures, using a form that is approved by the Institutional Review Board (IRB) or Medical Ethics Committee (EC).

The life expectancy of the subject is at least two years.

The subject has a lesion located in the internal carotid artery (ICA); the carotid bifurcation may be involved.

The target lesion is intended to be treated with a single stent.

Target ICA vessel diameter must be visually estimated to be:

• ≥2.5 mm and ≤7.0 for the Emboshield Pro (Gen 5)
• ≥ 2.8 mm and ≤6.2 for the Emboshield (Gen 3)

And

• ≥4.0 mm and ≤9.0 mm for the Xact Stent treatment area.

The subject has a carotid artery stenosis determined by ultrasound or angiography (visual estimate) to be:

• ≥50% for symptomatic subjects

Or

• ≥80% for asymptomatic subjects

Category I Anatomic Risk Factors

• Previous radiation treatment to the neck or radical neck dissection
• Target lesion is at or above the second vertebral body C2 (level of jaw)
• Inability to extend the head due to cervical arthritis or other cervical disorders
• Tracheostomy or tracheal stoma
• Laryngectomy
• Contralateral laryngeal nerve palsy
• Severe tandem lesions

Category II Co-morbid Risk Factors

• Previous CEA with significant restenosis (as defined for symptomatic or asymptomatic subjects)
• Total occlusion of the contralateral carotid artery
• Left ventricular ejection fraction < 35%
• Congestive Heart failure New York Heart Association (NYHA) Functional Class III or higher
• Dialysis dependent renal failure
• Canadian Cardiovascular Society Angina Classification III or higher or unstable angina
• Requires coronary artery bypass surgery, cardiac valve surgery, peripheral vascular surgery, or abdominal aortic aneurysm repair within 60 days

•≥80 years of age

• Myocardial infarction within previous 6 weeks
• Abnormal stress test. Treadmill, thallium or dobutamine echo are acceptable. The stress tests should be sufficiently abnormal to place the subject at increased risk for CEA. This includes subjects with two or more proximal diseased coronary arteries of >70% stenosis that have not or cannot be revascularized or <30 days since revascularization.
• Severe pulmonary disease, including at least one of the following: requires chronic O2 therapy; resting PO2 ≤60 mm Hg, Hematocrit ≥50%, FEV₁ or DLCO ≤50% of normal.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seemant Chaturvedi, MD

Role: STUDY_CHAIR

Wayne State University Stroke Program

William A Gray, MD

Role: STUDY_CHAIR

Columbia University

Jon Matsumura, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

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

Oregon Health & Science University

Portland, Oregon, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Pinnacle Health Hospital

Harrisburg, Pennsylvania, United States

St. Joseph's Medical center

Wyomissing, Pennsylvania, United States

Greenville Memorial Medical Center

Greenville, South Carolina, United States

Holston Valley Medical Center

Kingsport, Tennessee, United States

Mercy Medical Center West / Baptist Hospital of East Tennessee

Knoxville, Tennessee, United States

Austin Heart P.A.

Austin, Texas, United States

Presbyterian Heart Institute

Dallas, Texas, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

Chesapeake General Hospital

Norfolk, Virginia, United States

Bon Secours St. Mary's Hospital

Richmond, Virginia, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/22236885

Results of carotid artery stenting with distal embolic protection with improved systems: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) trial.

Other Identifiers

640-0071

Identifier Type: -

Identifier Source: org_study_id