NCT05365490

Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease

Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease. The ROADSTER 3 Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 344 (actual)
• Sponsor: Silk Road Medical · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is an open label, single arm, multi-center post-approval study for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and who are eligible for treatment using the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System. The study will enroll a maximum of 400 patients treated per protocol at 30-60 sites in the United States.

Conditions

• Carotid Artery Diseases

Interventions

Type	Name	Description
PROCEDURE	Transcarotid Artery Revascularization (TCAR)	Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-07-22
• Completion: 2025-07-22
• First posted: 2022-05-09
• Last updated: 2025-07-30

Locations

53 sites across 1 country: United States

Regulatory

• FDA-regulated device study