NCT03504228

Prospective Single Arm CAS - ROADSAVER Study

Name: Clinical Trial NCT03504228
Creator: Terumo Europe N.V.
Keywords: Carotid Artery Stenosis, Roadsaver, device, clinical trial, Belgium,Czech,France,Germany,Hungary,Latvia,Netherlands,North Macedonia,Poland,Portugal,Serbia,Slova

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

Terumo Europe N.V.·ClinicalTrials.gov·device·Device trialCompleted

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Study focus

Disease/Condition: Carotid Artery Stenosis
Drug/Device/Intervention: Roadsaver
Study type: Observational
Intervention type: device

Sponsor & location

Primary sponsor: Terumo Europe N.V.
Location: 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

Phase: N/A
Start date: Jan 23, 2018
End date: Jun 20, 2022
Enrollment: 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 arteryCarotid artery syndrome (hemispheric)Injury of carotid arteryAneurysm and dissection of carotid arteryOcclusion and stenosis of vertebral artery

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT03504228
Type: Device Trial

About this record

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.