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OPTIMAl Endovascular Exclusion of Consecutive Patient High-risk Carotid Plaque Using the MicroNet Covered Stent

NCT04234854 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-10-20

No results posted yet for this study

Summary

Prospective, multicentric, multispecialty, international, open-label, single arm study using per-protocol intravascular ultrasound \[IVUS, 20MHz electronic phase-array transducer\] to document the procedure result of an effective plaque exclusion from the vessel lumen.

Conditions

  • Carotid Artery Diseases

Interventions

DIAGNOSTIC_TEST

Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent

IVUS will be performed after stent postdilatation to determine the incidence of plaque prolapse. Additionally optimizing stent expansion with IVUS is left at operator discretion.

Sponsors & Collaborators

  • InspireMD

    collaborator INDUSTRY

  • John Paul II Hospital, Krakow

    lead OTHER

Principal Investigators

  • Piotr Musialek, MD, PhD · Department of Cardiac and Vascular Diseases, The John Paul II Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2022-12-31
Completion
2023-03-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04234854 on ClinicalTrials.gov