GORE Embolic Protection With Reverse Flow

NCT00594100 | Completed Phase 3 Results DMC

• 1 other identifier: NPS 05-05
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Carotid Artery Stenosis

Keywords

carotid artery stenosis; embolic protection device; GORE Neuro Protection System; GORE Flow Reversal System; reverse flow; proximal occlusion device; GNPS; Parodi; EMPiRE; distal embolization; minimizing risks of CAS; PAES

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Flow Reversal System Technical Success

  Procedure

• Flow Reversal System Success

  Procedure

• Stent Success

  Procedure

• Clinical Success

  24-48 Hours Post-Procedure

• Patency at 30 Days

  Treatment through 30-day visit window

Study Arms (1)

GFRS Pivotal Subjects

EXPERIMENTAL

All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).

Device: GORE Flow Reversal System (GFRS)

Interventions

GORE Flow Reversal System (GFRS) DEVICE

Carotid artery angioplasty and stenting with embolic protection

Also known as: Gore Neuro Protection System

GFRS Pivotal Subjects

Eligibility Criteria

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

You may qualify if:

• 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)

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

Study Sites (2)

Millard Fillmore Gates/Univ. of Buffalo

Buffalo, New York, 14209, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

• Parodi JC. Re: is flow reversal the best method of protection during carotid stenting? J Endovasc Ther. 2005 Jun;12(3):414-5. doi: 10.1583/05-1610L.1. No abstract available.

  PMID: 15943521 BACKGROUND

• Parodi JC, Schonholz 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.

  PMID: 17410059 BACKGROUND

• Parodi JC, Schonholz 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. doi: 10.1177/152660280200900104.

  PMID: 11958320 BACKGROUND

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: Andrew Garcia
• Organization: W. L. Gore & Associates

AGarcia@WLGore.com

(800) 437-8181

Study Officials

• Daniel Clair, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• L. N. Hopkins, M.D.

  Millard Fillmore Gates/Univ. of Buffalo

  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: December 20, 2007
• First Posted: January 15, 2008
• Study Start: July 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 27, 2013
• Results First Posted: May 5, 2009

Record last verified: 2013-12

Locations

US (2)