Carotid Artery Diseases
Conditions
Brief summary
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
Detailed description
This is an open label, single arm, multi-center post-approval study for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and who are eligible for treatment using the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System. The study will enroll a maximum of 400 patients treated per protocol at 30-60 sites in the United States.
Interventions
Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent
Sponsors
Silk Road Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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 3. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System 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 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. 6. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
Exclusion criteria
1. Patient meets any of the surgical high-risk criteria listed below. 1. Anatomic high risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hierarchical composite of Major Adverse Events (MAEs) | within 30 days of the index procedure | Hierarchical composite of Major Adverse Events (MAEs) defined as any death, stroke, or myocardial infarction within 30 days of the index procedure |
| Ipsilateral Stroke | within 31 to 365 days following the index procedure | Ipsilateral stroke within 31 days to 365 days following the index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | within 30 days of the index procedure | Death within 30 days of the index procedure |
| MI | within 30 days of the index procedure | MI within 30 days of the index procedure |
| Stroke/Death/MI | within 30 days of the index procedure | Stroke/Death/MI within 30 days of the index procedure |
| Ipsilateral Stroke | 31-365 days | Ipsilateral stroke within 31 to 365 days of the index procedure |
| Persistent cranial nerve injury | at 6 months and 1 year | Persistent cranial nerve injury at 6 months and 1 year |
| Incidence of cranial nerve injury | within 30 days of the index procedure | Incidence of cranial nerve injury within 30 days of the index procedure |
| Cardiac death | 1 year | Cardiac death at 1 year for patients who experienced an MI within 30 days of the index procedure |
| Access site complications | within 30 days of the index procedure | Access site complications (arterial/venous) |
| Serious Hematoma/Bleeding complications | within 30 days of the index procedure | Serious Hematoma/Bleeding complications (arterial/venous) |
| Rate of stent thrombosis or occlusion | within 30 days of the index procedure | Rate of stent thrombosis or occlusion within 30 days of the index procedure |
| Rate of dissection | within 30 days of the index procedure | Rate of dissection within 30 days of the index procedure (during index procedure or a reintervention procedure) |
| Rate of hierarchical ipsilateral stroke, death, and myocardial infarction | within 30 days of the index procedure | Rate of hierarchical ipsilateral stroke, death, and myocardial infarction within 30 days of the index procedure |
| Stroke | within 30 days of the index procedure | Stroke within 30 days of the index procedure |
Countries
United States
Outcome results
None listed