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Renal Perfusion Assessment in the Endovascular Treatment of Renal Artery Stenosis

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05603221
Collaborator
(none)
30
Enrollment
1
Location
43.8
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The clinical benefits of endovascular treatment in renal artery stenosis remain controversial. This study uses arterial spin labelling MRI and flat-panel detector parenchymal blood volume imaging to observe the change in renal perfusion after endovascular treatment in renal artery stenosis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Perfusion Assessment Using Arterial Spin Labelling MRI and Flat-panel Detector Parenchymal Blood Volume Imaging in Endovascular Treatment of Renal Artery Stenosis
    Actual Study Start Date :
    Nov 4, 2020
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Endovascular Group

    Patients who had successful endovascular revascularization

    Outcome Measures

    Primary Outcome Measures

    1. Perfusion of the target kidney assessed by Arterial Spin Labelling MRI [Changes from baseline renal perfusion at 2 months]

    2. Perfusion of the target kidney assessed by Flat-panel Detector Parenchymal Blood Volume Imaging [Changes from baseline renal perfusion immediately after endovascular intervention]

    Secondary Outcome Measures

    1. Blood pressure [Changes from baseline blood pressure at 1 year]

    2. Renal function [Changes from baseline renal function at 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients who provided informed consent

    • patients who were diagnosed with RAS by CTA, MRA, or Doppler ultrasonography

    • patients who were aged 18 years or older

    • patients whose intervened renal arteries were not completely occluded (confirmed by DSA)

    • the stenosis percentage exceeding 70%

    • patients who had uncontrolled blood pressure or impaired renal function

    • paitents whose affected kidney did not have total loss of function

    Exclusion Criteria:

    • were pregnant

    • had a history of renal transplantation or renal artery bypass surgery

    • were allergic to iodine contrast medium

    • had other contraindications of endovascular treatment

    • contraindications of MRI examinations

    • had technical failure in the endovascular treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05603221
    Other Study ID Numbers:
    • ASL and PBV in RAS
    First Posted:
    Nov 2, 2022
    Last Update Posted:
    Nov 2, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    renal artery stenosis
    renal perfusion
    Additional relevant MeSH terms:
    Renal Artery Obstruction
    Constriction, Pathologic

    Study Results

    No Results Posted as of Nov 2, 2022