Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease
Completed
Conditions studied: Carotid Artery Diseases
In brief
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 for adverse events from carotid endarterectomy
Key facts
- Study ID
- NCT05365490
- Run by
- Silk Road Medical
- People needed
- 344
- Starts
- 2022-09-01
- Expected to finish
- 2025-07-22
- Last updated by the study team
- 2025-07-30
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography.
- Patient must meet one of the following criteria regarding neurological symptom status and 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
- Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements).
- Patient is ≥18 and <80 years of age.
- Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board of the respective clinical site prior to the study procedure. This will be obtained prior to participation in the study.
- Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
You may not qualify if…
- Patient meets any of the surgical high-risk criteria listed below.
- 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 after index procedure
- Hostile Necks including prior neck irradiation, radical neck dissection, and cervical spine immobility
- Clinical high risk exclusion criteria:
- Patient is ≥80 years of age
- Patient has ≥2-vessel coronary artery disease (or has had revascularization procedure within the last 30 days) and/or angina
- Patient has history of unresolved angina - Canadian Cardiovascular Society (CCS) angina class 3 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 the procedure
- 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 is on dialysis
- Patient has an alternative source of cerebral embolus, including but not limited to:
- Chronic atrial fibrillation.
- Any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
- Knowledge of cardiac sources of thrombus. (If patient has left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma AND there is no confirmed thrombus on an echocardiogram performed within 3 months prior to index procedure, the patient may be eligible for enrollment).
Where it is running
- HonorHealth — Scottsdale, Arizona, United States
- Pima Heart & Vascular — Tucson, Arizona, United States
- University of California, San Diego (UCSD) — La Jolla, California, United States
- Sharp Grossmont — La Mesa, California, United States
- University of California, Los Angeles (UCLA) — Los Angeles, California, United States
- Yale University — New Haven, Connecticut, United States
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Morton Plant Hospital — Clearwater, Florida, United States
- Delray Medical Center — Delray Beach, Florida, United States
- Mount Sinai Medical Center — Miami Beach, Florida, United States
- AdventHealth Ocala — Ocala, Florida, United States
- Coastal Vascular & Interventional — Pensacola, Florida, United States
- Northside Vascular — Cumming, Georgia, United States
- Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
- Carle Health — Urbana, Illinois, United States
- Deaconess Research / Evansville Surgical Associates — Evansville, Indiana, United States
- Indiana University — Indianapolis, Indiana, United States
- Baton Rouge General — Baton Rouge, Louisiana, United States
- Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital — Lafayette, Louisiana, United States
- Maine Medical Center — Portland, Maine, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- McLaren Heart & Vascular — Bay City, Michigan, United States
- Corewell Health — Grand Rapids, Michigan, United States
- Abbott Northwestern — Minneapolis, Minnesota, United States
- Valley Vascular Consultants — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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