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Standard-risk patients who underwent carotid intervention for Carotid Artery Disease
N/A
Waitlist Available
Research Sponsored by Silk Road Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-years, 3-years, 4-years, and 5-years following the index procedure
Awards & highlights
No Placebo-Only Group
Summary
The study objective is to evaluate long-term outcomes for participants enrolled in the ROADSTER 3 study and treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS).
Eligible Conditions
- Carotid Artery Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-years, 3-years, 4-years, and 5-years following the index procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-years, 3-years, 4-years, and 5-years following the index procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
In-stent Restenosis
Ipsilateral Stroke
Ipsilateral Stroke Mortality
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Standard-risk patients who underwent carotid interventionExperimental Treatment1 Intervention
Symptomatic or asymptomatic patients with a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA), who underwent carotid artery revascularization.
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Who is running the clinical trial?
Silk Road MedicalLead Sponsor
9 Previous Clinical Trials
1,464 Total Patients Enrolled
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