Neuroguard IEP System for Carotid Artery Stenosis
(PERFORMANCE II Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a new device called the Neuroguard IEP System for people with significant narrowing of the carotid arteries. The device opens up the blocked artery, catches any loose particles, and keeps the artery open with a small tube. This group is targeted because they are at high risk for complications from traditional surgery.
Research Team
William A Gray, MD
Principal Investigator
Main Line Health
Ralf Langhoff, MD
Principal Investigator
Sankt Gertrauden Krankenhaus
Eligibility Criteria
This trial is for adults aged 20-80 with carotid artery stenosis who are at high risk for surgery. They must have a specific lesion size and location, be able to follow the study plan, and take dual antiplatelet therapy post-procedure. Pregnant or breastfeeding women, those with severe other illnesses, recent major surgeries or strokes, certain blood conditions, or known allergies to materials used in the procedure cannot participate.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Carotid artery stenting with Neuroguard IEP System (Procedure)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Contego Medical, Inc.
Lead Sponsor
Yale Cardiovascular Research Group
Collaborator
Advance Research Associates
Collaborator
CardioMed Device Consultants, LLC
Industry Sponsor
Iqvia Pty Ltd
Industry Sponsor
Medidata Solutions
Industry Sponsor