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Carotid Artery DiseasePROTECTNCT00402740

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

A study testing Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3) in people with Carotid Artery Disease, run by Abbott Medical Devices at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carotid Artery Disease
What is being tested?
Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
Type of treatment
Medical device
How many people
322 participants
Where
38 sitesUnited States
Study dates
Nov 2006to Oct 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Austin Heart P.A.

    Austin, Texas, 78756

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Millard Fillmore Hospital-Kaleida Health Systems

    Buffalo, New York, 14209

  • Our Lady of Lourdes Medical Center

    Camden, New Jersey, 08103

  • Northwestern University Memorial Hospital

    Chicago, Illinois, 60611

  • Presbyterian Heart Institute

    Dallas, Texas, 75231

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Parkview Hospital

    Fort Wayne, Indiana, 46805

  • Washington Hospital

    Fremont, California, 94538

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Greenville Memorial Medical Center

    Greenville, South Carolina, 29605

  • Pinnacle Health Hospital

    Harrisburg, Pennsylvania, 17110

  • Hawaii Permanente Medical Group-Kaiser Foundation Hospital

    Honolulu, Hawaii, 96819

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Memorial Hospital Jacksonville

    Jacksonville, Florida, 32216

  • Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Mercy Medical Center West / Baptist Hospital of East Tennessee

    Knoxville, Tennessee, 37934

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • El Camino Hospital

    Mountain View, California, 94040

  • Lenox Hill Hospital

    New York, New York, 10021

  • St. Michael's Medical Center

    Newark, New Jersey, 07102

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Chesapeake General Hospital

    Norfolk, Virginia, 23507

  • Munroe Regional Medical Center

    Ocala, Florida, 34475

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • WakeMed Hospital

    Raleigh, North Carolina, 27610

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • St. John's Hospital / Memorial Medical Center

    Springfield, Illinois, 62701

  • Stanford University Medical Center

    Stanford, California, 94305

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • St. Joseph's Medical center

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

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

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.

Being tested
Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
Keywords
Carotid, Artery, Disease, Stent, PROTECT, XACT, EMBOSHIELD
Medical subject headings
Carotid Artery Diseases, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Xact stent, Emboshield Pro (Gen 5), 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (4)

  1. Acute Device Success

    Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.

    Measured: Post-procedure

  2. 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.

    Measured: 30 Days

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

    Includes only each subject's first occurrence of each event.

    Measured: ≤30 days

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJun 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402740
Sponsor's protocol ID
640-0071
Acronym
PROTECT
Status last verified
May 2012
First submitted
20 Nov 2006
Last updated
20 Jun 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3) in people with Carotid Artery Disease, run by Abbott Medical Devices at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.

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