Neuroguard IEP System for Carotid Artery Stenosis

(PERFORMANCE II Trial)

Not currently recruiting at 42 trial locations

Overseen By Elizabeth K. Saylors, MSc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Contego Medical, Inc.

Must be taking: Dual antiplatelet therapy

Must not be taking: Anticoagulants, Anti-Xa agents

Disqualifiers: Cancer, Stroke, Atrial fibrillation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: Day of procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Neuroguard IEP System, a new device for treating carotid artery stenosis, which narrows the arteries in the neck that supply blood to the brain. The study targets patients at high risk for complications from traditional surgery to clear these arteries. Ideal participants have significant carotid artery blockage and are considered high-risk for standard surgical procedures due to other health issues.

As an unphased trial, this study allows patients to contribute to groundbreaking research that may lead to safer treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing and able to take dual antiplatelet therapy for at least 30 days after the procedure. If you are on anticoagulants like warfarin, you must stop them at least 14 days before the procedure.

What prior data suggests that the Neuroguard IEP System is safe for treating carotid artery stenosis?

Research has shown that the Neuroguard IEP System, used for treating blocked carotid arteries, is safe. In one study, no strokes or deaths occurred within 30 days after the procedure. Another study found that serious complications were rare, indicating a very low rate of major problems. This makes it a safer choice compared to older treatments. Overall, the Neuroguard IEP System is well-tolerated with few serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Neuroguard IEP System for carotid artery stenosis is unique because it combines a stent with an integrated embolic protection system. Unlike other treatments that might use separate devices for stenting and embolic protection, this system streamlines the process, potentially reducing procedure time and improving safety. Researchers are excited about this approach because it could lower the risk of stroke by capturing and removing debris during the procedure, offering a significant advantage over traditional methods.

What evidence suggests that the Neuroguard IEP System is effective for carotid artery stenosis?

Studies have shown that the Neuroguard IEP System effectively treats carotid artery stenosis, a condition where neck arteries narrow. In the PERFORMANCE I study, no strokes or deaths occurred within 30 days after the procedure. PERFORMANCE II found that the system had a very low rate of major complications compared to past data, demonstrating its safety and effectiveness. Additionally, the system reduces blockages caused by clots or debris during the procedure. This evidence suggests that the Neuroguard IEP System is a reliable option for managing carotid artery stenosis, especially for those at higher risk. Participants in this trial will undergo carotid artery stenting using the Neuroguard IEP System to further evaluate its effectiveness and safety. ^{1 2 3 5 6}

Who Is on the Research Team?

William A Gray, MD

Principal Investigator

Main Line Health

Ralf Langhoff, MD

Principal Investigator

Sankt Gertrauden Krankenhaus

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Carotid artery stenting procedure with the Neuroguard IEP System

Day of procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Visits at 30 days, 6 months, 12 months, 24 months, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Carotid artery stenting with Neuroguard IEP System

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

The IRON-Guard Registry aims to evaluate the safety and efficacy of the C-Guard stent in carotid artery stenting (CAS) for patients with significant carotid artery stenosis, involving 200 subjects across multiple centers.

The primary focus of the study is to assess the 30-day rate of major adverse events (MAE), including death, stroke, or myocardial infarction, which will help determine the clinical outcomes of using the C-Guard stent compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-initiated prospective Italian Registry of carotid stenting with the C-Guard mesh-stent: the IRON-Guard registry. Rationale and design. Setacci, C., Speziale, F., De Donato, G., et al.[2016]

The Angioguard emboli-capture guidewire system was technically feasible in 80% of cases during carotid artery stenting, effectively providing cerebral protection for most patients.

Despite the use of the filter device, new cerebral lesions were detected in 15% of patients after the procedure, indicating that microemboli can still occur, although no permanent neurological deficits were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical results of cerebral protection with a filter device during stent implantation of the carotid artery. Jaeger, H., Mathias, K., Drescher, R., et al.[2022]

The CGuard Carotid Embolic Protective Stent system was successfully used in 30 patients undergoing carotid artery stenting, achieving a 100% procedure success rate with no complications.

While 37% of patients developed new ischemic lesions immediately after the procedure, most of these lesions resolved by 30 days, indicating that the CGuard system may effectively reduce the risk of embolic events during the stent healing period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet). Schofer, J., Musiałek, P., Bijuklic, K., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10092178/

PERFORMANCE 1 study: Novel carotid stent system with ... Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879824014675

The PERFORMANCE II Trial: A Prospective Multicenter ... This study showed a remarkably low MAE rate compared with historical controls and demonstrates that the Neuroguard IEP system is a safe, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05845710?term=AREA%5BConditionSearch%5D(carotid%20disease%20OR%20%22%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=1

Direct Access Carotid Artery Stenting Using the ... A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of ...

4. evtoday.com evtoday.com/news/performance-ii-evaluates-contegos-neuroguard-iep-3-in-1-carotid-stent-system-at-2-years

PERFORMANCE II Evaluates Contego's Neuroguard IEP ... PERFORMANCE II Evaluates Contego's Neuroguard IEP Carotid Stent System at 2 Years · In a per-protocol analysis, the 30-day stroke rate was 1%.

5. mearis.cms.gov mearis.cms.gov/public/publications/ntap/NTP241004CNKB9

MEARIS™ | Publication | ntap | NTP241004CNKB9 - CMS The Neuroguard IEP system demonstrated effectiveness in reducing embolic events during carotid artery stenting. The 30-day all-stroke plus ipsilateral ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240009B.pdf

SSED Template - accessdata.fda.gov The study was a prospective, multi-center single-arm study designed to evaluate the safety and effectiveness of the Neuroguard IEP System for ...