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Prospective Single Arm CAS - ROADSAVER Study - Trial NCT03504228

Access comprehensive clinical trial information for NCT03504228 through Pure Global AI's free database. This phase not specified trial is sponsored by Terumo Europe N.V. and is currently Completed. The study focuses on Carotid Artery Stenosis. Target enrollment is 1967 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT03504228
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Trial Details
ClinicalTrials.gov • NCT03504228
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Prospective Single Arm CAS - ROADSAVER Study
Prospective, Single-arm, Multi-center, Observational Study to Further Confirm Safety and Efficacy of the Dual-layer Micromesh Roadsaver Stent for the Treatment of Carotid Artery Stenosis in Patients Eligible for Elective Stenting Procedure

Study Focus

Carotid Artery Stenosis

Roadsaver

Observational

device

Sponsor & Location

Terumo Europe N.V.

Aalst,Bonheiden,Dendermonde,Kortrijk,Leuven,Ostrava,Prague,Bayonne,Grenoble,Marseille,Nancy,Berlin,Berlin,Bruchsal,Flensburg,Frankfurt/Main,Karlsbad,Mannheim,Münster,Oldenburg,Passau,Radebeul,Suhl,Ulm, Belgium,Czech,France,Germany,Hungary,Latvia,Netherlands,North Macedonia,Poland,Portugal,Serbia,Slova

Timeline & Enrollment

N/A

Jan 23, 2018

Jun 20, 2022

1967 participants

Primary Outcome

The rate of Major Adverse Events (MAE)

Summary

Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to
 hospital routine practice in centers across Europe will be enrolled in the study. The maximum
 number of patients enrolled at each site will be not limited. Follow-ups are scheduled at
 discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up
 contacts via hospital visit and/or telephone.

ICD-10 Classifications

Occlusion and stenosis of carotid artery
Carotid artery syndrome (hemispheric)
Injury of carotid artery
Aneurysm and dissection of carotid artery
Occlusion and stenosis of vertebral artery

Data Source

ClinicalTrials.gov

NCT03504228

Device Trial