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Non-invasive Flow Measurements in Patients With Lower Extremity Arterial Disease (LEAD)

Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05689190
Collaborator
Leiden University Medical Center (Other)
30
Enrollment
1
Location
23.5
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Non-invasive Flow Measurements in Patients With Lower Extremity Arterial Disease (LEAD)
    Anticipated Study Start Date :
    Jan 16, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    patients

    Duplex ultrasound, angiogram, PTA intervention

    Outcome Measures

    Primary Outcome Measures

    1. blood flow [performed during a regular PTA intervention]

      Repeatability and correlation of angiographic hemodynamic measurements compared with the golden standard 2D duplex ultrasound.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients referred to the vascular surgery outpatient clinic (LUMC) with PAD

    • Age ≥18 years

    • Superficial femoral artery (SFA) stenosis (>70% occluded)

    • Elective for a percutaneous transluminal angioplasty procedure

    • Written informed consent

    Exclusion Criteria:

    • Contraindications to angiography, such as severe renal insufficiency (eGFR< 20)

    • Non-correctable bleeding disorder.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leiden University Medical Center Leiden Netherlands

    Sponsors and Collaborators

    • Philips Electronics Nederland B.V. acting through Philips CTO organization
    • Leiden University Medical Center

    Investigators

    • Principal Investigator: Carla SP van Rijswijk, Leiden University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Philips Electronics Nederland B.V. acting through Philips CTO organization
    ClinicalTrials.gov Identifier:
    NCT05689190
    Other Study ID Numbers:
    • ICBE-S-000115
    First Posted:
    Jan 19, 2023
    Last Update Posted:
    Jan 20, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Philips Electronics Nederland B.V. acting through Philips CTO organization
    blood flow measurements

    Study Results

    No Results Posted as of Jan 20, 2023