Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE-II)

  • STATUS
    Recruiting
  • End date
    Oct 5, 2024
  • participants needed
    305
  • sponsor
    Contego Medical, Inc.
Updated on 5 June 2022
aneurysm repair
carotid artery stenosis
angiography
stenosis
vascular surgery
stroke
bypass graft
pulmonary disease
coronary disease
coronary bypass
transient ischemic attack
endarterectomy
amaurosis fugax
ischemic attack
laryngeal nerve paralysis
cervical arthritis
neurologic symptoms
neck surgery
radical neck dissection
arterial stenosis
angioplasty balloon
laryngectomy

Summary

A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA). The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. Eligible patients between 20 and 80 years of age 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 ≥50% stenosis if symptomatic or ≥80% stenosis if asymptomatic (both defined by angiography using NASCET methodology). Symptomatic patients are defined as having stroke or TIA ipsilateral to the carotid lesion within 180 days of the procedure within the hemisphere supplied by the target vessel. Enrolled subjects will be followed at 30 days, 6 months, 12 months, 24 months and 36 months.

Details
Condition Carotid Artery Stenosis, Carotid Artery Diseases, Carotid Stenosis
Treatment Carotid artery stenting with Neuroguard IEP System
Clinical Study IdentifierNCT04201132
SponsorContego Medical, Inc.
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

General Inclusion Criteria
Male and non-pregnant female subjects whose age is ≥ 20 years and ≤ 80
Patient is willing and capable of complying with all study protocol requirements, including the specified follow-up visits and can be contacted by telephone
Patient or his/her authorized legal representative must sign a written informed consent form that has been approved by the local governing Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site
Patient is diagnosed with carotid artery stenosis treatable with carotid artery stenting and is considered a high operative risk for CEA
Patient is diagnosed with either
Symptomatic carotid stenosis ≥ 50% as determined by angiography using NASCET methodology. Symptomatic is defined as ipsilateral transient monocular blindness: amaurosis fugax; ipsilateral carotid transient ischemic attack (TIA), with neurologic symptoms persisting less than 24 hours; or ipsilateral non-disabling stroke within 180 days of the procedure; or
Asymptomatic carotid stenosis ≥ 80% as determined by angiography using NASCET methodology
Patient has a modified Rankin Scale score of ≤ 2 at the time of informed consent
Patient is willing and able to take dual antiplatelet therapy for a minimum of 30 days
Angiographic Inclusion Criteria
Target lesion located at the carotid bifurcation and/or proximal internal carotid artery (ICA)
Single de novo or restenotic (post carotid endarterectomy (CEA)) target lesion or severe tandem lesions that can be covered by a single Neuroguard stent
Target lesion length is ≤ 20 mm (for 30 mm stents) or is ≤ 30 mm (for 40 mm stents)
Index vessel diameter (segment covered by the mid-portion of the stent) between 4.0 mm and 6.0 mm at the site of the target lesion
Distal vessel diameter at the site of filter deployment is between 4.0 mm to 7.0 mm
Distal common carotid artery diameter (segment covered by proximal portion of the stent) between 4.0 mm and 8.0 mm
Sufficient landing zone exists in the cervical internal carotid artery distal to the target lesion to allow for the safe and successful deployment of both the primary embolic protection filter and the Neuroguard integrated filter
High Risk for CEA Conditions For inclusion in the study, a patient must meet at least one
significant anatomic or comorbid high risk conditions listed below. Patients at high risk
for CEA are defined as having significant comorbidities and/or anatomic risk factors and
would be poor candidates for carotid endarterectomy (CEA) in the opinion of a physician
High Anatomic Risk for CEA Conditions
Target lesion at or above C2 (level of jaw) or below the clavicle
Inability to extend the head due to cervical arthritis or other cervical disorders
History of radiation treatment to the neck or radical neck dissection
Prior head and neck surgery in the region of the carotid artery
Spinal immobility of the neck
Tracheostomy or tracheostoma
Hostile neck or surgically inaccessible lesion
Laryngeal palsy or laryngectomy
Severe tandem lesions (total length must be ≤ 30 mm and must be covered with one
stent)
Occlusion of the contralateral CCA or ICA
Severe bilateral ICA stenosis requiring treatment
High Co-morbid Risk Conditions for CEA
Patient is ≥ 70 years of age (maximum 80 years) at the time of enrollment
NYHA Class III or IV congestive heart failure (CHF)
Chronic obstructive pulmonary disease (COPD) with FEV1 < 50
Left ventricular ejection fraction (LVEF) ≤ 35%
Unstable angina
History of recent MI (Between 14 days and 6 weeks prior to index the procedure)
Coronary artery disease with two or more vessels with ≥ 70% stenosis
Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31
days after CAS procedure
Peripheral vascular surgery or abdominal aortic aneurysm repair is required between 31
days following CAS procedure
Contralateral laryngeal nerve paralysis
Restenosis following a prior carotid endarterectomy (CEA)

Exclusion Criteria

Life expectancy of less than one year, cancer with metastatic spread and/or undergoing
An evolving, acute, or recent disabling stroke in the last 30 days
active chemotherapy treatment, or currently requiring an organ transplantation
History of paroxysmal atrial fibrillation that requires chronic anticoagulation
Anticipated or potential sources of emboli including left ventricular aneurysm, severe
History of chronic atrial fibrillation
cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic
stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis
Acute myocardial infarction < 14 days prior to index procedure
known previously symptomatic PFO, left atrial thrombus, any intracardiac mass or DVT
or PE treated within the past 12 months
Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin
Dementia considered other than mild
inhibitor, or anti-Xa agents
Known hypersensitivity to nitinol or its components (e.g. nickel, titanium)
History of intracranial hemorrhage within 90 days prior to the index procedure
Any major surgical procedure (i.e. intraabdominal or intrathoracic surgery or any
History of GI bleed within 30 days prior to the index procedure
surgery / interventional procedure involving cardiac or vascular system) 30 days prior
to or following the index procedure
History of major disabling stroke with substantial residual disability (modified
Known hypersensitivity to contrast media that cannot be adequately premedicated
Rankin score ≥ 3)
Known severe carotid stenosis or complete occlusion contralateral to the target lesion
requiring treatment within 30 days of the index procedure
Other neurological deficit not due to stroke that may confound the neurological
assessments
Angiographic Exclusion Criteria
Total occlusion of the target carotid artery
Previously placed stent in the ipsilateral carotid artery
Chronic renal insufficiency (serum creatinine ≥ 2.5 ml/dL or estimated GFR < 30
cc/min)
History of severe hepatic impairment, malignant hypertension, and/or is morbidly
obese
Non-atherosclerotic carotid stenosis (e.g. dissection, fibromuscular dysplasia)
Hemoglobin (Hgb) < 8 gm/dL, platelet count < 100,000, INR > 1.5 (irreversible), or
heparin-induced thrombocytopenia
History or current indication of bleeding diathesis or coagulopathy including
Known mobile plaque or thrombus in the aortic arch
thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain
Type III aortic arch
an activated clot time at > 250 seconds
Contraindication to standard of care study medications, including antiplatelet therapy
or aspirin
Currently enrolled in another interventional device or drug study that has not yet
reached the primary endpoint
Severe calcification or vascular tortuosity of the target vessel that may preclude the
safe introduction of the sheath, guiding catheter, integrated EPD or stent. Severe
vascular tortuosity is defined as 2 or more bends of 90 degrees or more within 4 cm of
the target lesion
Qualitative characteristics of stenosis and stenosis-length of carotid bifurcation
(common carotid) and/or ipsilateral external carotid artery, that preclude the safe
introduction of the sheath
Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery
(CCA) that precludes safe, expeditious sheath placement or that will transmit a severe
loop to the internal carotid after sheath placement
Angiographic evidence of a mobile filling defect or fresh thrombus in the target
carotid artery
Presence of "string sign" of the target lesion (a tiny, long segment of contrast in
the true lumen of the artery)
Proximal/ostial CCA, innominate stenosis, or intracranial stenosis located distal to
the target stenosis that is more severe that target stenosis. Excessive
circumferential calcification of the target lesion is defined as > 3 mm of thickness
of calcification seen in orthogonal views on fluoroscopy
Patient in whom femoral access is not possible. Furthermore, occlusive or critical
iliofemoral disease, including severe tortuosity or stenosis that requires additional
endovascular procedures to facilitate aortic arch access or that prevents safe and
expeditious femoral access to the aortic arch
Arteriovenous malformations of the territory of the target carotid artery and cerebral
vasculature
Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis, tortuosity or
angulation of the aortic arch or origin of the innominate or common carotid arteries
that would preclude safe passage of the sheath and other endovascular devices to the
target artery as needed for carotid stenting
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