NCT03982420

The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Silk Road Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this evaluation is to document the incidence of post procedure DW-MRI lesions (relative to baseline) in patients treated with the transcarotid artery revascularization (TCAR) procedure.

Detailed description

This is a prospective, single-arm, multi-center evaluation of patients requiring carotid revascularization who are treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System. Both the ENROUTE Transcarotid NPS and ENROUTE Transcarotid Stent System have received CE mark and are commercially available in the European Union. Patients enrolled in this study will have been offered the TCAR intervention as part of standard of care for the treatment of carotid artery stenosis, regardless of whether or not they agree to be in the study. Therefore, the act of participation in this procedure will not be the determining factor in whether or not the patient receives the TCAR treatment. Subject participation means they agree to undergo two additional DW-MRI imaging procedures immediately after the procedure and at 30 days to determine whether there is an increase in new white lesions. Any other procedure other than the active collection of consent and data by the sponsor is standard of care for the treatment of carotid artery stenosis. These patients will be monitored to document the incidence of post procedure DW-MRI lesions (relative to baseline).

Conditions

• Carotid Artery Diseases
• Carotid Atherosclerosis
• Carotid Stenosis
• Carotid Artery Plaque
• Carotid Disease

Interventions

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

Timeline

• Start date: 2019-06-27
• Primary completion: 2022-01-19
• Completion: 2022-01-19
• First posted: 2019-06-11
• Last updated: 2026-01-14
• Results posted: 2026-01-14

Locations

6 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study