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

Carotid Artery Stenosis Clinical Trial

— EMBOLDEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766493
• Other study ID #: GEF-06-08
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2008
• Last updated: June 28, 2012
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: June 2012
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Device:
• GORE® Embolic Filter
Embolic protection during carotid stenting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure		30 days	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Neurologic Events	Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).	30 days	Yes