CompletedNot Applicable

Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)

United States178 participantsStarted 2023-10-05

Plain-language summary

The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of carotid artery stenosis in subjects at elevated risk for carotid endarterectomy (CEA). Eligible patients greater than or equal to 20 years of age and less than or equal to 82 years of age, are those who have been diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with greater than or equal to 50% stenosis if symptomatic or greater than or equal to 70% stenosis if asymptomatic.

Who can participate

Age range20 Years – 82 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 20 or ≤ 82 years of age.
✓. Subject is willing and capable of complying with and understands all study protocol requirements, including the specified follow-up visits, and can be contacted by telephone.
✓. Subject has signed a written informed consent form that has been approved by the local governing Institutional Review Board (IRB) of the respective clinical site.
✓. Subject is diagnosed with carotid artery stenosis treatable with carotid artery stenting via direct carotid access and is considered a high operative risk for carotid endarterectomy (CEA).
✓. Subject is diagnosed with either:
✓. Symptomatic carotid stenosis ≥ 50% as determined by angiography, CTA, or duplex ultrasound. Symptomatic is defined as having stroke, transient ischemic attack (TIA) in the ipsilateral hemisphere supplied by the target vessel carotid lesion or ipsilateral transient monocular blindness (amaurosis fugax) within 180 days prior to the procedure; or
✓. Asymptomatic carotid stenosis ≥ 70% as determined by angiography, CTA, or duplex ultrasound.
✓. Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).

What they're measuring

Composite of Major Adverse Events (MAE)

Timeframe: Within 30 days of the study procedure

Trial details

NCT IDNCT05845710

SponsorContego Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-12

View on ClinicalTrials.gov More Carotid Stenosis trials

Plain-language summary

Who can participate

Age range20 Years – 82 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 20 or ≤ 82 years of age.
✓. Subject is willing and capable of complying with and understands all study protocol requirements, including the specified follow-up visits, and can be contacted by telephone.
✓. Subject has signed a written informed consent form that has been approved by the local governing Institutional Review Board (IRB) of the respective clinical site.
✓. Subject is diagnosed with carotid artery stenosis treatable with carotid artery stenting via direct carotid access and is considered a high operative risk for carotid endarterectomy (CEA).
✓. Subject is diagnosed with either:
✓. Symptomatic carotid stenosis ≥ 50% as determined by angiography, CTA, or duplex ultrasound. Symptomatic is defined as having stroke, transient ischemic attack (TIA) in the ipsilateral hemisphere supplied by the target vessel carotid lesion or ipsilateral transient monocular blindness (amaurosis fugax) within 180 days prior to the procedure; or
✓. Asymptomatic carotid stenosis ≥ 70% as determined by angiography, CTA, or duplex ultrasound.
✓. Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).

Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria