Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT

NCT07458243 | Not Yet Recruiting FDA Device

• 1 other identifier: S10093
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a prospective, non-randomized, single-arm, multi-center post-market registry. To confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• • Procedural success

  technical success in the absence of a Major Adverse Event

  30-days of the index procedure

Interventions

transcarotid artery revascularization DEVICE

The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below: * Adequate femoral venous access * Common carotid artery reference diameter of at least 6 mm * Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will come from patients in each sites.

You may qualify if:

• \. Patients must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be \>50% as determined by an angiogram (CTA/MRA or catheter angiogram prior to the index procedure) and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented.
• OR Asymptomatic: Stenosis must be ≥70% as determined by angiogram (CTA/MRA or catheter angiogram prior to the index procedure) without any neurological symptoms within the prior 180 days.
• \. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and Carotid WALLSTENT Endoprosthesis (refer to IFU for requirements).
• \. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
• \. Patient is ≥18 years of age. 5. 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/Ethics Committee of the respective clinical site prior to the 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 has an alternative source of cerebral embolus, including but not limited to:
• Patient has chronic atrial fibrillation.
• Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
• Knowledge of any cardiac sources of emboli. (including but not limited to 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).
• Recently (\<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.
• Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA ≤ 6 months prior to index procedure) greater in severity than the lesion to be treated, cerebral aneurysm \> 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
• \. 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 or her at risk of hemorrhagic conversion during the procedure.
• \. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
• \. Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.
• \. Patient has an intracranial tumor. 6. Patient has an evolving stroke. 7. Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage).
• \. Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.
• \. Patient has an isolated hemisphere. 10. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.
• \. Myocardial Infarction within 72 hours prior to the intervention. 12. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.
• \. Occlusion or \[Thrombolysis In Myocardial Infarction Trial (TIMI 0)\] "string sign" \>1cm of the ipsilateral common or internal carotid artery.
• \. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) whether or not it is associated with an ulcerated target lesion.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04