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Procedure
Standard-risk patients requiring carotid intervention for Carotid Artery Disease
N/A
Waitlist Available
Led By Meghan Dermody, MD
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 1 year
Awards & highlights
No Placebo-Only Group
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
Eligible Conditions
- Carotid Artery Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hierarchical composite of Major Adverse Events (MAEs)
Secondary study objectives
Access site complications
Cardiac death
Death
+10 moreAwards & 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 requiring 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 require carotid artery revascularization.
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Who is running the clinical trial?
Silk Road MedicalLead Sponsor
9 Previous Clinical Trials
1,520 Total Patients Enrolled
Meghan Dermody, MDPrincipal InvestigatorLancaster General Hospital
Marc Schermerhorn, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
3 Previous Clinical Trials
786 Total Patients Enrolled
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