GORE Embolic Protection With Reverse Flow

Carotid Artery Stenosis Clinical Trial

— EMPiRE  

Official title:

The Embolic Protection With Reverse Flow Study of the GORE Neuro Protection System in Carotid Stenting of Subjects At High Risk for Carotid Endarterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594100
• Other study ID #: NPS 05-05
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2007
• Last updated: December 2, 2013
• Start date: July 2006
• Est. completion date: September 2008

Study information

• Verified date: December 2013
• 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

To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.

Description:

The GORE Flow Reversal System, manufactured by W. L. Gore & Associates, Inc., was developed as a proximal occlusion device to reverse the flow of blood in the carotid artery. It is designed to achieve embolic protection prior to crossing the lesion in the majority of cases in order to minimize the possibility of an adverse event occurrence.

The objective of this study is to assess the safety and effectiveness of the GORE Flow Reversal System when used to provide embolic protection during Carotid Artery Stent (CAS) procedures. Subjects diagnosed with carotid stenosis requiring revascularization and are at high risk for adverse events from CEA are eligible to participate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Carotid stenosis requiring revascularization and indicating either symptomatic status, with carotid stenosis = 50% OR asymptomatic status with carotid stenosis = 80%

• Target lesion is located in one of the following:(a) internal carotid artery (ICA) (b) bifurcation (c) common carotid artery (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)

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 Flow Reversal System (GFRS)
Carotid artery angioplasty and stenting with embolic protection

Locations

Country	Name	City	State
United States	Millard Fillmore Gates/Univ. of Buffalo	Buffalo	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

References & Publications (3)

Parodi JC, Schönholz C, Ferreira LM, Mendaro E, Ohki T. "Seat belt and air bag" technique for cerebral protection during carotid stenting. J Endovasc Ther. 2002 Feb;9(1):20-4. — View Citation

Parodi JC, Schönholz C, Parodi FE, Sicard G, Ferreira LM. Initial 200 cases of carotid artery stenting using a reversal-of-flow cerebral protection device. J Cardiovasc Surg (Torino). 2007 Apr;48(2):117-24. — View Citation

Parodi JC. Re: is flow reversal the best method of protection during carotid stenting? J Endovasc Ther. 2005 Jun;12(3):414-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Major Adverse Event (MAE) Rate	Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)	Treatment through 30-day visit window	Yes
Secondary	Flow Reversal System Technical Success	Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)	Procedure	Yes
Secondary	Flow Reversal System Success	Number of participants where the GORE Flow Reversal System was delivered, placed, reverse flow was established, and the balloon sheath and wire retrieved as outlined in the Instructions for Use without causing any adverse events during the procedure.	Procedure	Yes
Secondary	Stent Success	Number of participants where the FDA-approved stent was successfully delivered, deployed,and delivery system removed with an attainment of < 50% residual stenosis following stent placement, as assessed by the angiographic core laboratory.	Procedure	No
Secondary	Clinical Success	Number of participants with Flow Reversal System and Stent Success in the absence of death, emergency endarterectomy, repeat percutaneous transluminal angioplasty (PTA)/thrombolysis of the target vessel, stroke, or myocardial infarction (MI), as determined by the Clinical Events Committee (CEC).	24-48 Hours Post-Procedure	Yes
Secondary	Patency at 30 Days	Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.	Treatment through 30-day visit window	No