TerminatedNot Applicable

ROADSTER 3 Extended Follow-up Sub-Study

Stopped: The decision to close the study is not related to any safety concerns or newly identified risks to patients.

United States197 participantsStarted 2024-07-31

Plain-language 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).

Who can participate

Age range18 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS * Able to provide informed consent Exclusion Criteria: * Participants who have exited the ROADSTER 3 study early (i.e., prior to completion of protocol required follow-up) will not participate in the sub-study

What they're measuring

Ipsilateral Stroke

Timeframe: 2-years, 3-years, 4-years, and 5-years following the index procedure

Ipsilateral Stroke Mortality

Timeframe: 2-years, 3-years, 4-years, and 5-years following the index procedure

In-stent Restenosis

Timeframe: 2-years and 5-years following the index procedure

Trial details

NCT IDNCT06470815

SponsorSilk Road Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Carotid Artery Diseases trials