Neuroguard IEP System for Carotid Artery Stenosis

(PERFORMANCE II Trial)

Recruiting at 40 trial locations

Overseen By Elizabeth K. Saylors, MSc.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Contego Medical, Inc.

No Placebo Group

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

My target lesion fits within the size limit for the stent.

The artery in my neck fits the required size for a stent.

I can follow the study rules and attend all visits, and I'm reachable by phone.

Exclusion Criteria

My blood vessels are too twisted or hardened for safe device insertion.

The target lesion in the artery is mostly blocked and has reduced blood flow.

My tests show a blood clot in the artery of my neck.

Treatment Details

Interventions

• Carotid artery stenting with Neuroguard IEP System (Procedure)

Trial Overview The Neuroguard IEP System is being tested for its safety and effectiveness in treating carotid artery stenosis in patients who face high risks from traditional surgery. This single-arm study involves multiple centers where participants receive this particular stenting system.

Participant Groups

Group I: Carotid artery stenting Experimental Treatment 1 Intervention

Carotid artery stenting procedure with Neuroguard IEP System

Who Is Running the Clinical Trial?

Contego Medical, Inc.

Lead Sponsor

Trials

5

Recruited

820+

Yale Cardiovascular Research Group

Collaborator

Trials

11

Recruited

4,000+

Advance Research Associates

Collaborator

Trials

5

Recruited

840+

CardioMed Device Consultants, LLC

Industry Sponsor

Trials

6

Recruited

1,200+

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Medidata Solutions

Industry Sponsor

Trials

25

Recruited

25,600+