What side effects are associated with this type of intervention?

Common treatments for carotid stenosis, such as carotid artery stenting with embolic protection devices like the Neuroguard IEP System, can have side effects including procedural complications like bleeding, infection, and contrast dye reactions. Specific risks associated with stenting include restenosis, stroke, and transient ischemic attacks (TIAs). Embolic protection devices may also cause vessel wall injury or dislodge plaque, potentially leading to embolic events.

What prior FDA approvals exist?

The FDA has approved several devices for the treatment of carotid artery stenosis, focusing on stent placement and embolic protection. Notable examples include the Neuroguard IEP System, which is designed to treat carotid artery stenosis by providing embolic protection and facilitating stent placement. Other similar devices include the Acculink Carotid Stent System and the RX Acculink Carotid Stent System, both of which are used in conjunction with embolic protection devices like the Accunet and RX Accunet Embolic Protection Systems. These devices aim to reduce the risk of stroke by capturing and removing debris that may dislodge during the stenting procedure.

What other types of research exist?

Promising alternatives to the Neuroguard IEP System for treating carotid artery stenosis include the following devices and techniques: 1) The TCAR (TransCarotid Artery Revascularization) system, which combines direct carotid access with robust embolic protection; 2) The ENROUTE Transcarotid Neuroprotection System, designed to minimize stroke risk during carotid artery stenting; 3) The Mo.Ma Ultra Proximal Cerebral Protection Device, which provides proximal embolic protection during stenting procedures. These alternatives are gaining attention for their efficacy and safety profiles in recent clinical evaluations.

← Back to Search

Procedure

Neuroguard IEP System for Carotid Artery Stenosis (PERFORMANCE II Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for carotid stenosis include carotid endarterectomy (CEA) and carotid artery stenting (CAS). CEA involves the surgical removal of atherosclerotic plaque from the carotid artery to restore normal blood flow, reducing the risk of stroke. CAS, on the other hand, involves placing a stent to keep the artery open and using embolic protection devices to capture and remove debris that may dislodge during the procedure, preventing embolic strokes. The Neuroguard IEP System is an example of such a device, combining stent placement with integrated embolic protection to enhance safety and efficacy. These mechanisms are crucial for patients as they directly address the risk of stroke by ensuring that the blood flow is restored while minimizing the risk of embolic events during the intervention.

N/A

Waitlist Available

Led By William A Gray, MD

Research Sponsored by Contego Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Target lesion length is ≤ 20 mm (for 30 mm stents) or is ≤ 30 mm (for 40 mm stents)

Distal common carotid artery diameter (segment covered by proximal portion of the stent) is between 4.0 mm and 8.0 mm

Must not have

Severe calcification or vascular tortuosity of the target vessel that may preclude the safe introduction of the sheath, guiding catheter, distal filter, Neuroguard stent or Neuroguard filter

Angiographic evidence of a mobile filling defect or fresh thrombus in the target carotid artery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months, 24 months, 36 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical risks associated with stenting procedures such as bleeding at the catheter site, infection, allergic reaction to contrast media used during imaging tests (if premedication isn't effective), stroke due to clots dislodged during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

I have a diagnosed blockage in my neck artery, either with symptoms at 50% blockage or without symptoms at 80% blockage.

Select...

I have a narrowed carotid artery and am at high risk for surgery.

Select...

I am a man or a woman not pregnant or breastfeeding, aged 20 to 80.

Select...

I have a single new or recurring blockage in my carotid artery that can be treated with one stent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

My kidney function is low (creatinine ≥ 2.5 or GFR < 30).

Select...

I have a neurological condition that is not caused by a stroke.

Select...

I have or am suspected to have COVID-19.

Select...

I have not had a heart attack in the last 14 days.

Select...

I have had a severe stroke that left me with significant disabilities.

Select...

I cannot take standard medications like aspirin due to health reasons.

Select...

I have a history of irregular heartbeats needing long-term blood thinners.

Select...

My doctor expects I have less than a year to live due to my cancer spreading, and I am currently on chemotherapy or need an organ transplant.

Select...

I have heart or blood clot issues that could cause blockages.

Select...

I do not have conditions that make certain heart tests or procedures unsafe.

Select...

My carotid artery narrowing is not due to hardening of the arteries.

Select...

I have a severe blockage in my artery that is not the main one being treated.

Select...

I currently have a fever above 100.4F or an active infection.

Select...

I am currently experiencing a stroke.

Select...

I cannot have needle-based procedures due to severe blood vessel issues.

Select...

I have a bleeding disorder or can't take enough heparin to prevent clots.

Select...

I have a moving clot or plaque in my heart's main artery.

Select...

My aorta has a Type III arch.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months, 24 months, 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months, 24 months, 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months, 24 months, 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ipsilateral Stroke

MAE

Secondary study objectives

In-Stent Restenosis (ISR)

Major stroke

Minor stroke

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Carotid artery stentingExperimental Treatment1 Intervention

Carotid artery stenting procedure with Neuroguard IEP System

0 / 26Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for carotid stenosis include carotid endarterectomy (CEA) and carotid artery stenting (CAS). CEA involves the surgical removal of atherosclerotic plaque from the carotid artery to restore normal blood flow, reducing the risk of stroke. CAS, on the other hand, involves placing a stent to keep the artery open and using embolic protection devices to capture and remove debris that may dislodge during the procedure, preventing embolic strokes. The Neuroguard IEP System is an example of such a device, combining stent placement with integrated embolic protection to enhance safety and efficacy. These mechanisms are crucial for patients as they directly address the risk of stroke by ensuring that the blood flow is restored while minimizing the risk of embolic events during the intervention.