Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis
Pivotal Study of the MicroVention, Inc. Carotid Artery Stent System Used in Conjunction With the Nanoparasol® Embolic Protection System for the Treatment of Carotid Artery Stenosis in Patients at Elevated Risk for Adverse Events From Carotid Endarterectomy.(CONFIDENCE Trial)
Sponsor: Microvention-Terumo, Inc.
A NA clinical study on Carotid Artery Stenosis, this trial is ongoing. The trial is conducted by Microvention-Terumo, Inc. and has accumulated 17 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)Up to 295 patients will be enrolled for this study. All potential patients being considered for the study should have been diagnosed with significant carotid artery stenosis and be considered a high perioperative risk for carotid endarterectomy.
Patients will be evaluated through screening, pre-procedure, index procedure, post-procedure. Follow-up visits will be completed at 30 days, 6 months, and 12, 24, and 36 months post-procedure.
Up to 295 patients will be enrolled for this study. All potential patients being considered for the study should have been diagnosed with significant carotid artery stenosis and be considered a high perioperative risk for carotid endarterectomy.
Patients will be evaluated through screening, pre-procedure, index procedure, post-procedure. Follow-up visits will be completed at 30 days, 6 months, and 12, 24, and 36 months post-procedure.
Status Flow
Change History
17 versions recorded-
Sep 2025 — Present [monthly]
Unknown NA
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Mar 2025 — Sep 2025 [monthly]
Unknown NA
Status: Active Not Recruiting → Unknown
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Sep 2024 — Mar 2025 [monthly]
Active Not Recruiting NA
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting NA
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Mar 2023 — Jul 2024 [monthly]
Active Not Recruiting NA
▶ Show 12 earlier versions
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Apr 2022 — Mar 2023 [monthly]
Active Not Recruiting NA
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Mar 2022 — Apr 2022 [monthly]
Active Not Recruiting NA
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May 2021 — Mar 2022 [monthly]
Active Not Recruiting NA
Status: Recruiting → Active Not Recruiting
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Feb 2021 — May 2021 [monthly]
Recruiting NA
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Jan 2021 — Feb 2021 [monthly]
Recruiting NA
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Oct 2020 — Jan 2021 [monthly]
Recruiting NA
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Oct 2018 — Oct 2020 [monthly]
Recruiting NA
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Jun 2018 — Oct 2018 [monthly]
Recruiting NA
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Mar 2018 — Jun 2018 [monthly]
Recruiting NA
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Feb 2018 — Mar 2018 [monthly]
Recruiting NA
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Feb 2017 — Feb 2018 [monthly]
Recruiting NA
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Jan 2017 — Feb 2017 [monthly]
Recruiting NA
First recorded
Apr 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Microvention-Terumo, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .