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Procedure
Neuroguard IEP System for Carotid Artery Stenosis (PERFORMANCE II Trial)
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
PERFORMANCE II Trial Summary
This trial is testing the safety and effectiveness of the Neuroguard IEP System, a 3-in-1 carotid stent delivery system, for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).
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.Check my eligibility
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.See study design
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.
PERFORMANCE II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My target lesion fits within the size limit for the stent.
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The artery in my neck fits the required size for a stent.
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I have a diagnosed blockage in my neck artery, either with symptoms at 50% blockage or without symptoms at 80% blockage.
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I have a narrowed carotid artery and am at high risk for surgery.
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I am a man or a woman not pregnant or breastfeeding, aged 20 to 80.
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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.
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My tests show a blood clot in the artery of my neck.
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My kidney function is low (creatinine ≥ 2.5 or GFR < 30).
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I have a neurological condition that is not caused by a stroke.
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I have or am suspected to have COVID-19.
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I have not had a heart attack in the last 14 days.
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I have had a severe stroke that left me with significant disabilities.
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I cannot take standard medications like aspirin due to health reasons.
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I have a history of irregular heartbeats needing long-term blood thinners.
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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.
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I have heart or blood clot issues that could cause blockages.
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I do not have conditions that make certain heart tests or procedures unsafe.
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My carotid artery narrowing is not due to hardening of the arteries.
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I have a severe blockage in my artery that is not the main one being treated.
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I currently have a fever above 100.4F or an active infection.
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I am currently experiencing a stroke.
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I cannot have needle-based procedures due to severe blood vessel issues.
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I have a bleeding disorder or can't take enough heparin to prevent clots.
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I have a moving clot or plaque in my heart's main artery.
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My aorta has a Type III arch.
PERFORMANCE II Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ipsilateral Stroke
MAE
Secondary outcome measures
In-Stent Restenosis (ISR)
Major stroke
Minor stroke
+5 morePERFORMANCE II Trial Design
1Treatment groups
Experimental Treatment
Group I: Carotid artery stentingExperimental Treatment1 Intervention
Carotid artery stenting procedure with Neuroguard IEP System
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.
Find a Location
Who is running the clinical trial?
Yale Cardiovascular Research GroupOTHER
9 Previous Clinical Trials
3,155 Total Patients Enrolled
1 Trials studying Carotid Stenosis
229 Patients Enrolled for Carotid Stenosis
Advance Research AssociatesOTHER
4 Previous Clinical Trials
535 Total Patients Enrolled
1 Trials studying Carotid Stenosis
229 Patients Enrolled for Carotid Stenosis
CardioMed Device Consultants, LLCIndustry Sponsor
5 Previous Clinical Trials
886 Total Patients Enrolled
1 Trials studying Carotid Stenosis
229 Patients Enrolled for Carotid Stenosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 target lesion fits within the size limit for the stent.My tests show a blood clot in the artery of my neck.My kidney function is low (creatinine ≥ 2.5 or GFR < 30).I have or am suspected to have COVID-19.I have not had a heart attack in the last 14 days.You have dementia that is not considered mild.I have not had a brain bleed in the last 90 days.I have had a severe stroke that left me with significant disabilities.I have a severe narrowing or blockage in my neck artery needing treatment soon.The artery in my neck fits the required size for a stent.You have severe blockages or twists in the blood vessels leading to your brain that would make it unsafe to perform carotid stenting.I cannot take standard medications like aspirin due to health reasons.I can follow the study rules and attend all visits, and I'm reachable by phone.You are allergic to nitinol or its parts like nickel or titanium.I have a diagnosed blockage in my neck artery, either with symptoms at 50% blockage or without symptoms at 80% blockage.I have a high-risk condition for carotid endarterectomy.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.I have a narrowed carotid artery and am at high risk for surgery.I do not have conditions that make certain heart tests or procedures unsafe.I have a severe blockage in my artery that is not the main one being treated.My carotid artery narrowing is not due to hardening of the arteries.I have a neurological condition that is not caused by a stroke.I have heart or blood clot issues that could cause blockages.I have not had a GI bleed in the last 30 days.I have a history of irregular heartbeats needing long-term blood thinners.My target lesion is in the carotid artery near the neck.You have had a stent placed in the same carotid artery on the same side of your body.The narrowing and length of the carotid artery make it unsafe to insert the sheath.The angle or twist in the blood vessels in your neck makes it difficult to safely put in a tube for the study.I do not have brain conditions that would affect my study participation.The main artery in your neck is completely blocked.Your modified Rankin Scale score is 2 or lower when you agree to take part in the study.The size of the blood vessel where the filter will be placed is between 4.0 mm and 7.0 mm.I currently have a fever above 100.4F or an active infection.I am currently experiencing a stroke.Your hemoglobin is less than 8 gm/dL, platelet count is less than 100,000, or you have a blood clotting test result that shows an increased risk of bleeding.I haven't taken blood thinners like warfarin or direct thrombin inhibitors in the last 14 days.I cannot have needle-based procedures due to severe blood vessel issues.The blood vessel where the stent will be placed is between 4.0 mm and 6.0 mm wide.I have a bleeding disorder or can't take enough heparin to prevent clots.I have not had major surgery within the last 30 days.I am a woman who can have children and have a negative pregnancy test within the last 24 hours.I have a moving clot or plaque in my heart's main artery.There is enough space in the artery for the filters to be safely placed during the procedure.I am a man or a woman not pregnant or breastfeeding, aged 20 to 80.My aorta has a Type III arch.I or my legal representative have signed the consent form approved by the review board.I am willing and able to take blood-thinning medication for at least 30 days after my procedure.I have a single new or recurring blockage in my carotid artery that can be treated with one stent.
Research Study Groups:
This trial has the following groups:- Group 1: Carotid artery stenting
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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