NCT02529345

Clear-Road Trial, Investigating the Efficacy of the RoadSaver Stent

CLEAR-ROAD; a Physician-initiated Carotid Trial Investigating the Efficacy of Endovascular Treatment of Carotid Arterial Disease With the Multi-layer RoadSaver Stent

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.

Detailed description

It is a Prospective, multi-center, physician-sponsored clinical study. The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	RoadSaver stent	lesion treated with RoadSaver stent of Terumo

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-04-01
• Completion: 2017-05-01
• First posted: 2015-08-20
• Last updated: 2017-08-01

Locations

4 sites across 1 country: Belgium