Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease

R
Raghu Motaganahalli, MD

Primary Investigator

Enrolling By Invitation
18-79 years
All
Phase N/A
400 participants needed
1 Location

Overview

The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk fordverse events from carotid endarterectomy

Description

This is an open label, single arm, multi-center post-approval study for the treatment ofdard risk for adverse events from carotid endarterectomy who require carotidvascularization and who are eligible for treatment using the ENROUTE Transcarotid Stentystem and the ENROUTE Transcarotid Neuroprotection System. The study will enroll a maximumd per protocol at 30-60 sites in the United States.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Carotid Artery Diseases
  • Age: Between 18 Years - 79 Years
  • Gender: All

Inclusion Criteria:
  1. Patient has a discrete lesion located in the internal carotid artery (ICA) with orwithout involvement of the contiguous common carotid artery (CCA) determined by duplexultrasound, CT/CTA, MR/MRA or angiography.
  2. Patient must meet one of the following criteria regarding neurological symptom statusd degree of stenosis:
    Symptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or≥50% stenosis of the common or internal carotid artery by angiogram
    OR
    Asymptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or≥60% stenosis of the common or internal carotid artery by angiogram
  3. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotectionystem and ENROUTE Stent System (refer to IFU for requirements).
  4. Patient is ≥18 and <80 years of age.
  5. Patient understands the nature of the procedure and has provided a signed informedusing a form that has been reviewed and approved by the Institutional ReviewBoard/Ethics Committee of the respective clinical site prior to the study procedure.This will be obtained prior to participation in the study.
  6. Patient is willing to comply with the protocol requirements and return to thequired clinical evaluations.
Exclusion Criteria:
  1. Patient meets any of the surgical high-risk criteria listed below.
    1. Anatomic high risk exclusion criteria:
      • Contralateral carotid artery occlusion
      • Tandem stenoses in the ICA >70% diameter reducing
      • High cervical carotid artery stenosis above the C2 vertebra
      • Restenosis after prior ipsilateral carotid endarterectomy
      • Bilateral carotid artery stenosis requiring treatment within 30 days afterdex procedure
      • Hostile Necks including prior neck irradiation, radical neck dissection, andvical spine immobility
    2. Clinical high risk exclusion criteria:
      • Patient is ≥80 years of age
      • Patient has ≥2-vessel coronary artery disease (or has had revascularizationdure within the last 6 months) and/or angina
      • Patient has history of angina - Canadian Cardiovascular Society (CCS) angina3 or 4 OR unstable angina
      • Patient has congestive heart failure (CHF) - New York Heart Association(NYHA) Functional Class III or IV
      • Patient has a known severe left ventricular dysfunction - LVEF <30%
      • Patient has had a myocardial infarction within 6 weeks prior to thedure
      • Patient has severe obstructive pulmonary disease (COPD) with either:
        • FEVI <50% predicted OR
        • chronic oxygen therapy OR
        • resting PO2 of ≤60 mmHG (room air)
      • Patient has permanent contralateral cranial and/or laryngeal nerve injury
      • Patient has chronic renal insufficiency (serum creatinine ≥2.5 mg/dL) or isdialysis
  2. Patient has an alternative source of cerebral embolus, including but not limited to:
    1. Chronic atrial fibrillation.
    2. Any episode of paroxysmal atrial fibrillation within the past 6 months, orhistory of paroxysmal atrial fibrillation requiring chronic anticoagulation.
    3. Knowledge of cardiac sources of emboli. (If patient has left ventricularurysm, intracardiac filling defect, cardiomyopathy, aortic or mitralhetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis,defect, atrial septal aneurysm, or left atrial myxoma AND there ared emboli on an echocardiogram performed within 3 months prior to indexdure, the patient may be eligible for enrollment).
    4. Recently implanted heart valve (either surgically or endovascularly) within 60days prior to index procedure with confirmed emboli on echocardiogram.
    5. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial(as determined by angiography or CTA/MRA ≤6 months prior to indexdure) greater in severity than the lesion to be treated, cerebral aneurysm>5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or otherbnormal angiographic findings.
  3. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months
    or has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him orher at risk of hemorrhagic conversion during the procedure.
  4. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
  5. Patient with a history of major stroke attributable to either carotid artery (CVA orbolus) with major neurological deficit (NIHSS ≥5 OR mRS ≥3) likely tound study endpoints within 1 month of index procedure.
  6. Patient has an intracranial tumor.
  7. Patient has an evolving stroke.
  8. Patient has neurologic illnesses within the past 2 years characterized by fleeting ord neurologic deficit which cannot be distinguished from TIA or stroke, includingbut not limited to: moderate to severe dementia, partial or secondarily generalizedzures, complicated or classic migraine, tumor or other space-occupying brainubdural hematoma, cerebral contusion or other post-traumatic lesions,demyelinating disease, or intracranial hemorrhage.
  9. Patient has had a TIA or amaurosis fugax within 48 hrs. prior to the procedure
  10. Patient has an isolated hemisphere
  11. Patient had or will have open heart (e.g., CABG), endovascular stent procedure, valvevention, vascular surgery, other major operation within 30 days of the indexdure.
  12. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCAgnificant CCA inflow lesion.
  13. Occlusion or [Thrombolysis in Myocardial Infarction Trial (TIMI 0)] "string sign" >1cmhe ipsilateral common or internal carotid artery.
  14. An intraluminal filling defect (defined as an endoluminal lucency surrounded byultiple angiographic projections, in the absence of angiographicvidence of calcification) whether or not it is associated with an ulcerated target.
  15. Ostium of CCA requires revascularization.
  16. Patient has an open stoma in the neck.
  17. Female patients who are pregnant or may become pregnant.
  18. Patient has history of intolerance or allergic reaction to any of the studydications or stent materials (refer to ENROUTE stent IFU), including aspirin (ASA),dine, clopidogrel, statin or contrast media (that can't be pre-medicated).Patients must be able to tolerate statins (or a permitted non-statin substitute) and abination of ASA and ticlopidine or ASA and clopidogrel or alternative P2Y12hibitor..
  19. Patient has a life expectancy <5 years without contingencies related to other medical,urgical, or interventional procedures or is at High Risk as per the Wallaert Score.y and scoring per the Wallaert Score is to be performed.
  20. Patient has primary, recurrent or metastatic malignancy and does not have independenty performed by the treating oncologist or an appropriateher than the physician performing TCAR.
  21. Patient has an unresolved/uncorrected bleeding disorder.
  22. Patient has a known allergy to nitinol
  23. Patient has an active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]), as determinedby a positive COVID-19 test, or has been previously diagnosed with COVID-19 withurological sequelae that could confound endpoint assessments (e.g., baseline mRS>3).

Updated on 01 Aug 2024. Study ID: SRM-2022-01
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