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Procedure

Standard-risk patients requiring carotid intervention for Carotid Artery Disease

N/A
Recruiting
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

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hierarchical composite of Major Adverse Events (MAEs)
Secondary outcome measures
Access site complications
Cardiac death
Death
+10 more

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.

Find a Location

Who is running the clinical trial?

Silk Road MedicalLead Sponsor
9 Previous Clinical Trials
1,538 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
~87 spots leftby May 2025
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