ACTIVE_NOT_RECRUITING

Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)

Talk to us

Conditions

Carotid StenosisCarotid Artery Diseasescarotid artery stent

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of carotid artery stenosis in subjects at elevated risk for carotid endarterectomy (CEA). Eligible patients greater than or equal to 20 years of age and less than or equal to 80 years of age, are those who have been diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with greater than or equal to 50% stenosis if symptomatic or greater than or equal to 70% stenosis if asymptomatic.

Official Title

Protection Against Emboli During caRotid Artery Stenting Using a Neuroguard IEP® Direct 3-in-1 Delivery System Comprised oF a pOst-dilation Balloon, integRated eMbolic Filter, and A Novel Carotid stEnt - the PERFORMANCE III Study

Quick Facts

Study Start:2023-10-05
Study Completion:2025-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05845710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Sean Lyden, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
D. Christopher Metzger, MD
PRINCIPAL_INVESTIGATOR
OhioHealth Research Institute

Study Locations (Sites)

Honor Health
Scottsdale, Arizona, 85258
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Manatee Memorial Hospital
Bradenton, Florida, 34208
United States
Delray Medical Center
Delray Beach, Florida, 33484
United States
Mount Sinai Vascular Institute
Miami Beach, Florida, 33140
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
Indiana University Methodist Hospital
Indianapolis, Indiana, 46202
United States
Southcoast Health
New Bedford, Massachusetts, 02720
United States
McLaren Center for Research and Innovation
Bay City, Michigan, 48708
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
University at Buffalo Neurosurgery - Jacobs Institute
Buffalo, New York, 14203
United States
Sisters of Charity Hospital
Buffalo, New York, 14214
United States
Northwell Health
Lake Success, New York, 11042
United States
Mount Sinai Medical Center
New York, New York, 10029
United States
UNC Hospital
Chapel Hill, North Carolina, 27514
United States
Atrium Health - Sanger Heart and Vascular
Charlotte, North Carolina, 28204
United States
North Carolina Heart and Vascular Research
Raleigh, North Carolina, 27607
United States
TriHealth (Bethesda North Hospital)
Cincinnati, Ohio, 45242
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
OhioHealth Research Institute
Columbus, Ohio, 43214
United States
St. Francis Hospital
Tulsa, Oklahoma, 74136
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health
Greenville, South Carolina, 29615
United States
Vanderbilt University
Nashville, Tennessee, 37232-5545
United States
St. David's Healthcare
Austin, Texas, 78756
United States
Baylor Scott and White Research Institute
Dallas, Texas, 75246
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Contego Medical, Inc.

  • Sean Lyden, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
  • D. Christopher Metzger, MD, PRINCIPAL_INVESTIGATOR, OhioHealth Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-05
Study Completion Date2025-12-15

Study Record Updates

Study Start Date2023-10-05
Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

  • carotid artery stent

Additional Relevant MeSH Terms

  • Carotid Stenosis
  • Carotid Artery Diseases