GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN) (EMBOLDEN)

GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (GORE EMBOLDEN)

Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: GORE® Embolic Filter

Detailed Description

Continuous advances in angioplasty techniques and the development of low-profile, flexible, tapered nitinol stents designed specifically for carotid applications have made CAS a viable alternative to CEA. Advances in embolic protection technology will assist in moving CAS forward as a universally accepted procedure. While the GORE® Embolic Filter is similar in many ways to other currently available filters, it has been designed to provide optimal vessel wall apposition. Bench tests suggest that the wall apposition may provide improved filter efficiency, thereby minimizing embolization of particles downstream and potentially decreasing adverse clinical effects. In addition, preclinical testing suggests that the GORE® Embolic Filter has improved deliverability, including torque ability and lesion cross that may improve the ability of the system to access and treat tight lesions in tortuous anatomy. Thus, the purpose of this multi-center clinical study is to assess the safety and effectiveness of the GORE® Embolic Filter when used to provide cerebral embolic protection during carotid artery angioplasty and stenting.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is either:

   • Symptomatic (amaurosis fugax in the hemisphere supplied by the target vessel, TIA or non-disabling stroke within 6 months of the procedure) with carotid stenosis ≥50% as diagnosed by angiography using NASCET methodology, OR
   • Asymptomatic with carotid stenosis ≥80% as diagnosed by angiography using NASCET methodology

2. Target lesion is located in one of the following:

   • ICA
   • bifurcation
   • CCA proximal to the bifurcation
3. At Anatomic risk for adverse events from CEA (e.g., restenosis after a prior CEA) or at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)

Exclusion Criteria:

• Recent surgical procedure within 30 days before or after the stent procedure
• Uncontrolled sensitivity to contrast media
• Renal Insufficiency
• Recent evolving, acute stroke within 21 days of study evaluation
• Myocardial infarction within 72 hours prior to stent procedure
• History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS)
• Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS)

Angiographic Exclusion Criteria:

• Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow
• Total occlusion of the ipsilateral carotid artery
• Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch
• Presence of a filling defect, thrombus, occlusion or "string sign" in the target vessel
• Severe lesion calcification restricting stent deployment
• Carotid stenosis located distal to target stenosis that is more severe than target stenosis
• >50% stenosis of the CCA proximal to target vessel
• Known mobile plaque in the aortic arch

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GORE® Embolic Filter; Subjects treated with the GORE® Embolic Filter and an FDA-approved carotid stent.	Device: GORE® Embolic Filter; Embolic protection during carotid stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).	Post Procedure
Clinical Success	Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.	30 days
Access Site Complications	Access Site Complications defined as the presence of a large hematoma (>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.	30 days
Neurologic Events	Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).	30 days

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: William A. Gray, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 3, 2008
• First Submitted That Met QC Criteria: October 3, 2008
• First Posted (Estimate): October 6, 2008

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: August 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: carotid artery stenosis; embolic protection device; distal embolic filter; minimizing risks of carotid artery stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: GEF-06-08