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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00402740
First received: November 20, 2006
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Carotid Artery Disease
Device: Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.


Secondary Outcome Measures:
  • Acute Device Success [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]
    Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.

  • Procedural Success [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    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.

  • Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax [ Time Frame: ≤30 days ] [ Designated as safety issue: Yes ]
    Includes only each subject's first occurrence of each event.

  • Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 322
Study Start Date: November 2006
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
    Other Names:
    • Xact stent
    • Emboshield Pro (Gen 5)
    • Emboshield (Gen 3)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402740

  Show 38 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Study Chair: Seemant Chaturvedi, MD Wayne State University Stroke Program
Study Chair: William A Gray, MD Columbia University College of Physicians and Surgeons
Study Chair: Jon Matsumura, MD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00402740     History of Changes
Other Study ID Numbers: 640-0071
Study First Received: November 20, 2006
Results First Received: May 7, 2012
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Carotid
Artery
Disease
Stent
PROTECT
XACT
EMBOSHIELD

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014