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NCT06653387 · ClinicalTrials.gov registry record · NA

A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach

A NA study of Carotid Artery Diseases, sponsored by InspireMD.

Recruiting
Registry status
NA
Development phase
50
Enrollment target
8
Study locations

NCT06653387 is a NA study of Carotid Artery Diseases that is actively recruiting participants, run by InspireMD. The registered enrollment target is 50 participants, below the 1,666-participant average among 6 other Carotid Artery Diseases trials with a reported enrollment target (97% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT06653387, a NA study of Carotid Artery Diseases, is actively recruiting participants, sponsored by InspireMD.

RECRUITING
Registry status
NA
Development phase
50 participants
Enrollment target
8
Study locations

Study Summary

The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.

Conditions Studied

Carotid Artery Diseases

Interventions

  • DEVICE CGuard Prime 80cm stent system

Study Locations (8)

New York

  • Mount Sinai Hospital - New York
  • University of Rochester - Rochester

California

  • UC Davis Health - Sacramento

Indiana

  • Indiana University School of Medicine - Indianapolis

Minnesota

  • Allina - Minneapolis

Missouri

  • Washington University School of Medicine - St Louis

Montana

  • Benefis Health System - Great Falls

Ohio

  • TriHealth - Cincinnati

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-11-20
Est. Completion 2027-11-20
Phase NA

Sponsor

InspireMD

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06653387

The ClinicalTrials.gov registry entry for NCT06653387 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,666-participant average among 6 other Carotid Artery Diseases trials with a reported enrollment target (97% lower). The listed sponsor is InspireMD, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Carotid Artery Diseases appearing as the primary indexed condition, and to 1 intervention - of which CGuard Prime 80cm stent system is the first listed.

NCT06653387 reports 8 study locations spanning 7 distinct geographic areas - top geographies include New York, California, Indiana.

Frequently Asked Questions

What is clinical trial NCT06653387 about?

NCT06653387 is a clinical study titled "A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach". The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk f...

What is the current status of trial NCT06653387?

This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-11-20. Estimated completion is 2027-11-20.

What conditions does trial NCT06653387 study?

This clinical trial studies the following conditions: Carotid Artery Diseases.

What interventions are being tested in trial NCT06653387?

The interventions under investigation include: CGuard Prime 80cm stent system (DEVICE).

Who is sponsoring clinical trial NCT06653387?

This trial is sponsored by InspireMD, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06653387 being conducted?

This trial has 8 study locations across California, Indiana, Minnesota, Missouri, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.