Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-30 @ 4:48 PM
Study NCT ID:
NCT04201132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2019-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System
Sponsor:
Contego Medical, Inc.
Organization:
Study Overview
Official Title:
Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1 Delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter and a Novel Carotid Stent - the PERFORMANCE II Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERFORMANCE II
Brief Summary:
A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).
Detailed Description:
The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. Eligible patients must be between 20 and 80 years of age and diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with ≥50% stenosis if symptomatic), or, ≥80% stenosis if asymptomatic (both defined by angiography using NASCET methodology). Symptomatic patients are defined as having stroke or TIA ipsilateral to the carotid lesion within 180 days of the procedure within the hemisphere supplied by the target vessel. Enrolled subjects will be followed at 30 days, 6 months, 12 months, 24 months and 36 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: