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

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00600327
First received: January 14, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Transient Ischemic Attack
Thromboembolic Stroke
Stroke Prevention
Device: EndoTex™ NexStent™
Device: Filter Wire EZ™
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Major clinical events at one-year defined as any death, stroke or myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • NexStent™ technical success [ Time Frame: post surgery ] [ Designated as safety issue: Yes ]
  • FilterWire EZ™ technical success [ Time Frame: post surgery ] [ Designated as safety issue: Yes ]
  • Overall system technical success [ Time Frame: post surgery ] [ Designated as safety issue: Yes ]
  • Angiographic success [ Time Frame: post procedure ] [ Designated as safety issue: Yes ]
  • Procedure Success [ Time Frame: 24 hours post procedure ] [ Designated as safety issue: Yes ]
  • Restenosis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 488
Study Start Date: December 2001
Study Completion Date: June 2007
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: EndoTex™ NexStent™
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.
Device: Filter Wire EZ™
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.

  Eligibility

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

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600327

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
El Camino Hospital
Mountain View, California, United States, 94040
Hoag Hospital
Newport Beach, California, United States, 92663
United States, Louisiana
Oschner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Millard Fillmore Gates Hospital
Buffalo, New York, United States, 14209
Lenox Hill Hospital
New York, New York, United States, 10021
Columbia - Weill Cornell Division of Vascular Surgery
New York, New York, United States, 10021
United States, North Carolina
Carolina Medical Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17101
Allegheny General Hospital
Pittsburg, Pennsylvania, United States, 15212
University of Pittsburgh (UPMC-Shadyside)
Pittsburgh, Pennsylvania, United States, 15232
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Argentina
Favaloro Institute
Buenos Aires, Argentina, 1093
Germany
Cardiovascular Center Bethanien, Germany
Frankfurt, Germany, 60389
Leipzig Heart Center
Leipzig, Germany, 04289
Sieburg Heart Center, Germany
Siegburg, Germany, 53721
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Cheryl Fontana, BSN Boston Scientific Corporation
Principal Investigator: L. Nelson Hopkins, MD Millard Filmore/Gates Hospital
Principal Investigator: Subbarao Myla, MD Hoag Hospital
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheryl Fontana, Boston Scientific
ClinicalTrials.gov Identifier: NCT00600327     History of Changes
Other Study ID Numbers: S2209
Study First Received: January 14, 2008
Last Updated: January 14, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Stroke
thrombosis
thromboembolic
Transient Ischemic Attack
TIA

Additional relevant MeSH terms:
Cerebral Infarction
Ischemic Attack, Transient
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014