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

NCT00402740 | Completed Results DMC

• 1 other identifier: 640-0071
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 38

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

Keywords

Carotid; Artery; Disease; Stent; PROTECT; XACT; EMBOSHIELD

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.

  Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.

  3 years

Secondary Outcomes (4)

• Acute Device Success

  Post-procedure

• Procedural Success

  30 Days

• Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax

  ≤30 days

• Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.

  3 years

Interventions

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

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).

Also known as: Xact stent, Emboshield Pro (Gen 5), Emboshield (Gen 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≥80% for asymptomatic subjects

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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (38)

Washington Hospital

Fremont, California, 94538, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Memorial Hospital Jacksonville

Jacksonville, Florida, 32216, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34475, United States

Location

Hawaii Permanente Medical Group-Kaiser Foundation Hospital

Honolulu, Hawaii, 96819, United States

Location

Northwestern University Memorial Hospital

Chicago, Illinois, 60611, United States

Location

St. John's Hospital / Memorial Medical Center

Springfield, Illinois, 62701, United States

Location

Parkview Hospital

Fort Wayne, Indiana, 46805, United States

Location

St. Vincent Hospital and Health Care Center

Indianapolis, Indiana, 46260, United States

Location

Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

McLaren Regional Medical Center

Flint, Michigan, 48532, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Our Lady of Lourdes Medical Center

Camden, New Jersey, 08103, United States

Location

St. Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

Millard Fillmore Hospital-Kaleida Health Systems

Buffalo, New York, 14209, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

WakeMed Hospital

Raleigh, North Carolina, 27610, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

Pinnacle Health Hospital

Harrisburg, Pennsylvania, 17110, United States

Location

St. Joseph's Medical center

Wyomissing, Pennsylvania, 19610, United States

Location

Greenville Memorial Medical Center

Greenville, South Carolina, 29605, United States

Location

Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Mercy Medical Center West / Baptist Hospital of East Tennessee

Knoxville, Tennessee, 37934, United States

Location

Austin Heart P.A.

Austin, Texas, 78756, United States

Location

Presbyterian Heart Institute

Dallas, Texas, 75231, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Chesapeake General Hospital

Norfolk, Virginia, 23507, United States

Location

Bon Secours St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Links

• 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.

MeSH Terms

Conditions

Carotid Artery Diseases; Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ellen Travis, MS, NFP
• Organization: Abbott Vascular

Ellen.Travis@av.abbott.com

408 845-1512

Study Officials

• Seemant Chaturvedi, MD

  Wayne State University Stroke Program

  STUDY CHAIR

• William A Gray, MD

  Columbia University

  STUDY CHAIR

• Jon Matsumura, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 20, 2012
• Results First Posted: June 20, 2012

Record last verified: 2012-05

Locations

US (38)