Renal Perfusion Assessment in the Endovascular Treatment of Renal Artery Stenosis

Renal Artery Stenosis Clinical Trial

Official title:

Perfusion Assessment Using Arterial Spin Labelling MRI and Flat-panel Detector Parenchymal Blood Volume Imaging in Endovascular Treatment of Renal Artery Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603221
• Other study ID #: ASL and PBV in RAS
• Status: Recruiting
• Start date: November 4, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2022
• Source: Peking Union Medical College Hospital
• Contact: Bao Liu
• Phone: 010-69152592
• Email: liubao72[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Renal Artery Obstruction
• Renal Artery Stenosis

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion of the target kidney assessed by Arterial Spin Labelling MRI		Changes from baseline renal perfusion at 2 months
Primary	Perfusion of the target kidney assessed by Flat-panel Detector Parenchymal Blood Volume Imaging		Changes from baseline renal perfusion immediately after endovascular intervention
Secondary	Blood pressure		Changes from baseline blood pressure at 1 year
Secondary	Renal function		Changes from baseline renal function at 1 year