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

Carotid Artery Disease Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402740
• Other study ID #: 640-0071
• Status: Completed
• Phase: N/A
• First received: November 20, 2006
• Last updated: May 17, 2012
• Start date: November 2006
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria Subject must be = 18 years of age.

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

High-risk inclusion criteria for either anatomical or co-morbid risk factors are present. The subject must fulfill at least one of the criteria, Category I or II risk factors, listed below to meet the inclusion criteria.

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Austin Heart P.A.	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Millard Fillmore Hospital-Kaleida Health Systems	Buffalo	New York
United States	Our Lady of Lourdes Medical Center	Camden	New Jersey
United States	Northwestern University Memorial Hospital	Chicago	Illinois
United States	Presbyterian Heart Institute	Dallas	Texas
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	McLaren Regional Medical Center	Flint	Michigan
United States	Parkview Hospital	Fort Wayne	Indiana
United States	Washington Hospital	Fremont	California
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Greenville Memorial Medical Center	Greenville	South Carolina
United States	Pinnacle Health Hospital	Harrisburg	Pennsylvania
United States	Hawaii Permanente Medical Group-Kaiser Foundation Hospital	Honolulu	Hawaii
United States	Terrebonne General Medical Center	Houma	Louisiana
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	St. Vincent Hospital and Health Care Center	Indianapolis	Indiana
United States	Memorial Hospital Jacksonville	Jacksonville	Florida
United States	Holston Valley Medical Center	Kingsport	Tennessee
United States	Mercy Medical Center West / Baptist Hospital of East Tennessee	Knoxville	Tennessee
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	El Camino Hospital	Mountain View	California
United States	Lenox Hill Hospital	New York	New York
United States	St. Michael's Medical Center	Newark	New Jersey
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Chesapeake General Hospital	Norfolk	Virginia
United States	Munroe Regional Medical Center	Ocala	Florida
United States	Oregon Health & Science University	Portland	Oregon
United States	WakeMed Hospital	Raleigh	North Carolina
United States	Bon Secours St. Mary's Hospital	Richmond	Virginia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	St. John's Hospital / Memorial Medical Center	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	St. Joseph's Medical center	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Acute Device Success	Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.	Post-procedure	No
Secondary	Procedural Success	Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.	30 Days	Yes
Secondary	Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax	Includes only each subject's first occurrence of each event.	=30 days	Yes
Secondary	Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.		3 years	Yes

External 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.