NCT05365490
Completed
Not Applicable
Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease. The ROADSTER 3 Study
ConditionsCarotid Artery Diseases
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Silk Road Medical
- Enrollment
- 400
- Locations
- 53
- Primary Endpoint
- Hierarchical composite of Major Adverse Events (MAEs)
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Hierarchical composite of Major Adverse Events (MAEs)
Time Frame: 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
Time Frame: within 31 to 365 days following the index procedure
Ipsilateral stroke within 31 days to 365 days following the index procedure
Secondary Outcomes
- Ipsilateral Stroke(31-365 days)
- Persistent cranial nerve injury(at 6 months and 1 year)
- Death(within 30 days of the index procedure)
- Rate of hierarchical ipsilateral stroke, death, and myocardial infarction(within 30 days of the index procedure)
- Rate of dissection(within 30 days of the index procedure)
- Incidence of cranial nerve injury(within 30 days of the index procedure)
- Stroke(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)
- Access site complications(within 30 days of the index procedure)
- Cardiac death(1 year)
- Serious Hematoma/Bleeding complications(within 30 days of the index procedure)
- Rate of stent thrombosis or occlusion(within 30 days of the index procedure)
Investigators
Study Sites (53)
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