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

NCT00600327 | Completed Phase 3

• 1 other identifier: S2209
• Study Type: interventional
• Target: 488
• Locations: 3 countries
• Sites: 19

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.

Conditions

Transient Ischemic Attack; Thromboembolic Stroke; Stroke Prevention

Keywords

Stroke; thrombosis; thromboembolic; Transient Ischemic Attack; TIA

Outcome Measures

Primary Outcomes (2)

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

  1 year

• 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.

  1 year

Secondary Outcomes (7)

• NexStent™ technical success

  post surgery

• FilterWire EZ™ technical success

  post surgery

• Overall system technical success

  post surgery

• Angiographic success

  post procedure

• Procedure Success

  24 hours post procedure

Study Arms (1)

1

EXPERIMENTAL

Device: EndoTex™ NexStent™; Device: Filter Wire EZ™

Interventions

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.

1

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (19)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Hoag Hospital

Newport Beach, California, 92663, United States

Location

Oschner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Millard Fillmore Gates Hospital

Buffalo, New York, 14209, United States

Location

Columbia - Weill Cornell Division of Vascular Surgery

New York, New York, 10021, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

Carolina Medical Center

Charlotte, North Carolina, 28203, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Harrisburg Hospital

Harrisburg, Pennsylvania, 17101, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh (UPMC-Shadyside)

Pittsburgh, Pennsylvania, 15232, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Favaloro Institute

Buenos Aires, 1093, Argentina

Location

Cardiovascular Center Bethanien, Germany

Frankfurt, 60389, Germany

Location

Leipzig Heart Center

Leipzig, 04289, Germany

Location

Sieburg Heart Center, Germany

Siegburg, 53721, Germany

Location

Related Publications (1)

• 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.

  PMID: 20542776 DERIVED

MeSH Terms

Conditions

Ischemic Attack, Transient; Stroke; Thrombosis

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Study Officials

• Cheryl Fontana, BSN

  Boston Scientific Corporation

  STUDY DIRECTOR

• L. Nelson Hopkins, MD

  Millard Filmore/Gates Hospital

  PRINCIPAL INVESTIGATOR

• Subbarao Myla, MD

  Hoag Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 24, 2008
• Study Start: December 1, 2001
• Primary Completion: March 1, 2005
• Study Completion: June 1, 2007
• Last Updated: January 24, 2008

Record last verified: 2008-01

Locations

DE (3); US (15); AR (1)