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

Primary Purpose

Transient Ischemic Attack, Thromboembolic Stroke, Stroke Prevention

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EndoTex™ NexStent™
Filter Wire EZ™
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transient Ischemic Attack focused on measuring Stroke, thrombosis, thromboembolic, Transient Ischemic Attack, TIA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Hospital and Medical Center
  • El Camino Hospital
  • Hoag Hospital
  • Oschner Clinic Foundation
  • Union Memorial Hospital
  • Albany Medical College
  • Millard Fillmore Gates Hospital
  • Columbia - Weill Cornell Division of Vascular Surgery
  • Lenox Hill Hospital
  • Carolina Medical Center
  • Cleveland Clinic Foundation
  • Harrisburg Hospital
  • University of Pittsburgh (UPMC-Shadyside)
  • Allegheny General Hospital
  • Swedish Medical Center
  • Favaloro Institute
  • Cardiovascular Center Bethanien, Germany
  • Leipzig Heart Center
  • Sieburg Heart Center, Germany

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

NexStent™ technical success
FilterWire EZ™ technical success
Overall system technical success
Angiographic success
Procedure Success
Restenosis
Target vessel revascularization

Full Information

First Posted
January 14, 2008
Last Updated
January 14, 2008
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00600327
Brief Title
Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™
Acronym
CABERNET
Official Title
Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Thromboembolic Stroke, Stroke Prevention
Keywords
Stroke, thrombosis, thromboembolic, Transient Ischemic Attack, TIA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
488 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
EndoTex™ NexStent™
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Filter Wire EZ™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Major clinical events at one-year defined as any death, stroke or myocardial infarction
Time Frame
1 year
Title
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
Secondary Outcome Measure Information:
Title
NexStent™ technical success
Time Frame
post surgery
Title
FilterWire EZ™ technical success
Time Frame
post surgery
Title
Overall system technical success
Time Frame
post surgery
Title
Angiographic success
Time Frame
post procedure
Title
Procedure Success
Time Frame
24 hours post procedure
Title
Restenosis
Time Frame
1 year
Title
Target vessel revascularization
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Fontana, BSN
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
L. Nelson Hopkins, MD
Organizational Affiliation
Millard Filmore/Gates Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Subbarao Myla, MD
Organizational Affiliation
Hoag Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Oschner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Millard Fillmore Gates Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Columbia - Weill Cornell Division of Vascular Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolina Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Harrisburg Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
University of Pittsburgh (UPMC-Shadyside)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Favaloro Institute
City
Buenos Aires
ZIP/Postal Code
1093
Country
Argentina
Facility Name
Cardiovascular Center Bethanien, Germany
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Leipzig Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Sieburg Heart Center, Germany
City
Siegburg
ZIP/Postal Code
53721
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20542776
Citation
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.
Results Reference
derived

Learn more about this trial

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

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