Renal Perfusion Assessment in the Endovascular Treatment of Renal Artery Stenosis

NCT05603221 | Unknown

• 1 other identifier: ASL and PBV in RAS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Artery Stenosis

Keywords

renal artery stenosis; renal perfusion

Outcome Measures

Primary Outcomes (2)

• Perfusion of the target kidney assessed by Arterial Spin Labelling MRI

  Changes from baseline renal perfusion at 2 months

• Perfusion of the target kidney assessed by Flat-panel Detector Parenchymal Blood Volume Imaging

  Changes from baseline renal perfusion immediately after endovascular intervention

Secondary Outcomes (2)

• Blood pressure

  Changes from baseline blood pressure at 1 year

• Renal function

  Changes from baseline renal function at 1 year

Study Arms (1)

Endovascular Group

Patients who had successful endovascular revascularization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was conducted in renal artery stenosis patients aged 18 to 80 years with uncontrolled blood pressure or impaired renal function, who were intended for endovascular treatment. CTA, MRA, or Doppler ultrasonography were used for the assessment of the stenosis percentage of renal artery. Subjects with technical failure were excluded in order to reduce the influence of other variables.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Renal Artery Obstruction

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Bao Liu

CONTACT

010-69152592; liubao72@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 2, 2022
• Study Start: November 4, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

CN (1)