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Transient Ischemic AttackPhase 3CABERNETNCT00600327

Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™

A Phase 3 study testing EndoTex™ NexStent™ and Filter Wire EZ™ in people with Transient Ischemic Attack and Thromboembolic Stroke, run by Boston Scientific Corporation at 19 sites in 3 countries.

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 primary objective of this study is to demonstrate the safety of the NexStent for treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire distal embolic protection device. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EndoTex™ NexStent™ and Filter Wire EZ™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
19 sitesin 3 countries
Study dates
Dec 2001to Jun 2007
Phase
Phase 3
Are there results?
None posted in the registry

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

  • patient is greater than or equal to 18 years of age.
  • Anticipated patient life expectancy is of at least one year from the date of the index procedure.
  • Lesion is located in the common carotid artery (CCA) and/or the internal carotid artery (ICA) or the carotid bifurcation.
  • Target vessel is the only vessel being treated at this intervention and the lesion is less than or equal to 30 mm and can be treated with a single stent.
  • Vessel to be treated is between 4.0 mm and 9.0 mm in diameter.
  • Patient can be either symptomatic or asymptomatic; Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke, TIA and/or amaurosis fugax in the hemisphere supplied by the target vessel within 180 days of the procedure.
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  • Patient can be either symptomatic or asymptomatic; Asymptomatic: Stenosis must be greater than or equal to 60% as determined by angiogram without any neurological symptoms.
  • Distal vessel "landing zone" for placement of the FilterWire must be between 3.5 mm and 5.5 mm in diameter with visual angiographic recommendations as described in the IFU.
  • Female patients with no childbearing potential or a documented negative pregnancy test (urine or blood) within 10 days of the index procedure.
  • Patient (or their legal guardian) understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
  • Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
  • Patient must fulfill at least one of the following Class I: Unstable angina, LVEF less than 30%, CHF class III or class IV, dialysis dependent renal failure, severe COPD, requirement for staged CABG or valve replacement post carotid index procedure,Previous carotid endarterectomy with significant restenosis, total occlusion of the contralateral carotid artery, Previous radiation treatment to the neck or radical neck dissection, Target lesion is at or above the second vertebral body C2 or below the clavicle, Inability to extend the head due to cervical arthritis or other cervical disorders, Tracheostomy or tracheal stoma,Presence of laryngeal nerve palsy, Bilateral carotid artery stenosis as determined by angiography.
  • If a patient does not meet Class I criteria, a patient must meet two of the follwing class II criteria: Patient is greater than or equal to 75 years of age, Myocardial infarction within previous 6 weeks, Requires staged peripheral vascular surgery (i.e. abdominal aortic aneurysm repair) or other major surgery post carotid index procedure, Two or more proximal or major diseased coronary arteries with greater than or equal to 70% stenosis that have not or cannot be revascularized.

Who cannot join

  • Previously placed stent in target vessel.
  • Total occlusion of target vessel (ICA or CCA).
  • Angiographically visible thrombus.
  • Carotid string sign (a tiny, long segment of contrast in the true lumen of the artery, aneurysmal pouch formation, and the distal location of the arteriopathy) with poor visualization of the distal vessel.
  • Vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the targeted carotid artery.
  • Vessel anatomy precluding use of stent system or distal protection system.
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  • Presence of carotid artery dissection.
  • Requirement for staged CABG, valve replacement or abdominal aortic aneurysm procedure 30 days before or after the index procedure.
  • Evidence of a major disabling stroke within the previous 30 days.
  • Patient has an evolving stroke or has experienced a major stroke (NIHSS score greater than or equal to 15) within 3 months.
  • History of intracranial hemorrhage within the past 12 months.
  • Any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe, e.g. morbid obesity, history of chronic hypertension that is not controlled by medical therapy.
  • Contraindication to heparin, aspirin, clopidogrel (Plavix®), X-ray contrast or ticlopidine (Ticlid®)in cases of intolerance to clopidogrel.
  • History of liver failure with elevated prothrombin time.
  • History or current indication of bleeding diathesis or coagulopathy.
  • Hgb <8 gm/dl (unless on dialysis), platelet count < 50,000, WBC >15,000, INR > l.5 (irreversible) or heparin-associated thrombocytopenia.
  • Known cardiac sources of emboli not under treatment with anticoagulant therapy.
  • Atherosclerotic disease involving adjoining vessels precluding safe placement of the guiding catheter or sheath.
  • Planned treatment of non-target lesion within 30 days.
  • Other abnormal angiographic findings that indicate the patient is at risk of a stroke due to a problem other that the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation (AVM) of the cerebral vasculature.
  • Dementia or confusion.
  • The patient is enrolled in another study protocol.
  • Patient may not participate in another investigational trial up to 12 months post-index procedure.

Trial locations and contacts

19 sites in 3 countries.

19 sites in 3 countries

United States15 sites

  • Albany Medical College

    Albany, New York, 12208

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Millard Fillmore Gates Hospital

    Buffalo, New York, 14209

  • Carolina Medical Center

    Charlotte, North Carolina, 28203

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Harrisburg Hospital

    Harrisburg, Pennsylvania, 17101

  • El Camino Hospital

    Mountain View, California, 94040

  • Oschner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia - Weill Cornell Division of Vascular Surgery

    New York, New York, 10021

  • Lenox Hill Hospital

    New York, New York, 10021

  • Hoag Hospital

    Newport Beach, California, 92663

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh (UPMC-Shadyside)

    Pittsburgh, Pennsylvania, 15232

  • Swedish Medical Center

    Seattle, Washington, 98104

Other trials in United States

Germany3 sites

  • Cardiovascular Center Bethanien, Germany

    Frankfurt, 60389

  • Leipzig Heart Center

    Leipzig, 04289

  • Sieburg Heart Center, Germany

    Siegburg, 53721

Other trials in Germany

Argentina1 site

  • Favaloro Institute

    Buenos Aires, 1093

Other trials in Argentina

About this study

The primary objective of this study is to demonstrate the safety of the NexStent for treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire distal embolic protection device. The rates will be compared to an Objective Performance Criterion (OPC) derived from historic data from high-risk patients undergoing surgical intervention with Carotid endarterectomy. Patients included in this study are those at higher risk for complications associated with CEA.

Being tested
EndoTex™ NexStent™, Filter Wire EZ™
Keywords
Stroke, thrombosis, thromboembolic, Transient Ischemic Attack, TIA
Medical subject headings
Ischemic Attack, Transient, Stroke, Thrombosis

What participants receive

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

  • EndoTex™ NexStent™Device

    EndoTex™ NexStent™ is a flexible, fine mesh Nitinol stent used to treat patients that are at high risk of adverse events from carotid endarterectomy and require carotid revascularization of a target vessel that has a reference diameter between 4mm and 9mm and stenosis that is less than 30mm in length.

  • Filter Wire EZ™Device

    EPI Fliter Wire EZ™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.

Study groups in NCT00600327
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Device: EndoTex™ NexStent™; Device: Filter Wire EZ™

What is being measured

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

  1. Major clinical events at one-year defined as any death, stroke or myocardial infarction

    Measured: 1 year

  2. 30-day event rate defined as any death, stroke or myocardial infarction less than or equal to 30-days post-procedure; plus the 31-day to 12-month event rate defined as any ipsilateral stroke including any death as a result of an ipsilateral stroke.

    Measured: 1 year

Secondary outcomes (7)

  1. NexStent™ technical success

    Measured: post surgery

  2. FilterWire EZ™ technical success

    Measured: post surgery

  3. Overall system technical success

    Measured: post surgery

  4. Angiographic success

    Measured: post procedure

  5. Procedure Success

    Measured: 24 hours post procedure

  6. Restenosis

    Measured: 1 year

  7. Target vessel revascularization

    Measured: 1 year

Timeline

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

  1. First posted24 Jan 2008 (estimated)
  2. Study startDec 2001
  3. Primary completionMar 2005
  4. Study completionJun 2007

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00600327
Sponsor's protocol ID
S2209
Acronym
CABERNET
Status last verified
Jan 2008
First submitted
14 Jan 2008
Last updated
24 Jan 2008
Results posted
No
Data monitoring committee
No

Publications

  • Hopkins LN, Myla SV, Grube E, Eles G, Dave R, Jaff MR, Allocco DJ. Carotid artery revascularisation in high-surgical-risk patients with the NexStent and the FilterWire EX/EZ: 3-year results from the CABERNET trial. EuroIntervention. 2010 Apr;5(8):917-24.

    PubMed 20542776

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EndoTex™ NexStent™ and Filter Wire EZ™ in people with Transient Ischemic Attack and Thromboembolic Stroke, run by Boston Scientific Corporation at 19 sites in 3 countries.

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 13 inclusion and 23 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 24 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Germany, Argentina. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Major clinical events at one-year defined as any death, stroke or myocardial infarction (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT00600327, which also lists 1 linked publication.

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 24 Jan 2008.

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