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

NCT00766493 | Completed Phase 3 Results DMC

• 1 other identifier: GEF-06-08
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carotid Artery Stenosis

Keywords

carotid artery stenosis; embolic protection device; distal embolic filter; minimizing risks of carotid artery stenting

Outcome Measures

Primary Outcomes (1)

• Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure

  30 days

Secondary Outcomes (4)

• Device Success

  Post Procedure

• Clinical Success

  30 days

• Access Site Complications

  30 days

• Neurologic Events

  30 days

Study Arms (1)

GORE® Embolic Filter

EXPERIMENTAL

Subjects treated with the GORE® Embolic Filter and an FDA-approved carotid stent.

Device: GORE® Embolic Filter

Interventions

GORE® Embolic Filter DEVICE

Embolic protection during carotid stenting

GORE® Embolic Filter

Eligibility Criteria

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

You may qualify if:

• 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
• Target lesion is located in one of the following:
• ICA
• bifurcation
• CCA proximal to the bifurcation
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• W.L.Gore & Associates: lead

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Bryan Randall
• Organization: W. L. Gore & Associates

BRandall@WLGore.com

(800) 437-8181

Study Officials

• William A. Gray, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 29, 2016
• Results First Posted: August 7, 2012

Record last verified: 2016-08