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

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

305 Participants Needed

Trial Summary

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 data supports the effectiveness of the Neuroguard IEP System treatment for carotid artery stenosis?

The PERFORMANCE I study shows that the Neuroguard IEP System, which includes a stent and a filter to catch debris, is safe and feasible for treating carotid artery stenosis. Additionally, other studies suggest that using protection devices during carotid artery stenting can reduce complications and improve outcomes. ^{1 2 3 4 5}

Is the Neuroguard IEP System safe for humans?

The Neuroguard IEP System has been evaluated for safety in treating carotid artery stenosis, showing feasibility in the PERFORMANCE I study. However, similar devices like AngioGuard have been associated with complications such as vasospasm (sudden narrowing of blood vessels) and minor strokes, indicating potential risks. ^{1 4 5 6 7}

How is the Neuroguard IEP System treatment different from other treatments for carotid artery stenosis?

The Neuroguard IEP System is unique because it combines a carotid stent with an integrated embolic filter and a post-dilation balloon, which helps protect the brain from debris during the procedure and ensures the artery is properly widened. ^{1 4 5 8 9}

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.

Timeline

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

Treatment Details

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.

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+

Findings from Research

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Endovascular treatment of carotid artery stenosis: retrospective study of 79 patients treated with stenting and angioplasty with and without cerebral protection devices. [2022]

3. France pubmed.ncbi.nlm.nih.gov

First clinical experience with the GARDEX EPD: a novel embolic protection device for carotid artery stenting. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical results of cerebral protection with a filter device during stent implantation of the carotid artery. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Complication with an embolic protection device during carotid angioplasty. [2022]

6. Italy 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. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Significance of blood aspiration in carotid artery stenting with Angioguard XP. [2012]

8. United States 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). [2017]

9. France pubmed.ncbi.nlm.nih.gov

Real-time angiography in endovascular revascularization of intracranial atherosclerotic internal carotid artery stenosis under proximal balloon protection: "Retrograde suction-injection" technique and literature review. [2023]