Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING 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

NCT06653387 · View on ClinicalTrials.gov ↗

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

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

30 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InspireMD, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06653387 reports 8 study locations spanning 7 distinct geographic areas — top geographies include New York, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06653387?

The interventions under investigation include: CGuard Prime 80cm stent system (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06653387?

This trial is sponsored by InspireMD, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial