ROADSTER 3 Extended Follow-up Sub-Study | NCT06470815 | Trialant

ROADSTER 3 Extended Follow-up Sub-Study | NCT06470815 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard-risk patients who underwent carotid 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.	Procedure: Transcarotid Artery Revascularization (TCAR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcarotid Artery Revascularization (TCAR)	Procedure	Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ipsilateral Stroke	Ipsilateral stroke at 2-years, 3-years, 4-years, and 5-years following the index procedure	2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral Stroke Mortality	Ipsilateral stroke mortality at 2-years, 3-years, 4-years, and 5-years following the index procedure	2-years, 3-years, 4-years, and 5-years following the index procedure
In-stent Restenosis	In-stent restenosis ≥70% at 2-years and 5-years	2-years and 5-years following the index procedure

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Meghan Dermody, MD	Lancaster General Hospital	Principal Investigator
Jeffrey Jim, MD	Abbott Northwestern Minneapolis Heart Institute Foundation	Principal Investigator
Marc Schermerhorn, MD	Beth Israel Deaconess Medical Center	Principal Investigator