FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis (FARS)

April 27, 2026 updated by: Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

Fractional Flow Reserve-Guided Revascularization in Atherosclerotic Renal Artery Stenosis: A Randomized Controlled Trial

For patients with atherosclerotic renal artery stenosis, the results of randomized controlled trials published in recent years have failed to demonstrate that renal artery stenting is superior to optimal medical therapy. However, these studies still have limitations.

Fractional flow reserve (FFR) has been extensively studied in coronary artery disease, and it has been established that FFR-guided revascularization is superior to both angiography-guided percutaneous coronary intervention and medical therapy alone. Whether FFR can guide interventional treatment in patients with renal artery stenosis and hypertension is currently a hot topic in the field of renal artery stenosis research.

Eligible patients meeting the inclusion criteria were enrolled. Pharmacologically induced FFR values were measured as the baseline. Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR < 0.8 underwent stent implantation. Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100037
        • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Principal Investigator:
          • Xiongjing Jiang, MD
        • Contact:
        • Sub-Investigator:
          • Hui Dong, MD,PhD
      • Chongqing, China, 400016
        • Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Shanghai, China, 200025
        • Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
      • Tianjin, China, 300192
        • Tianjin First Central Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
        • Contact:
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Fuwai Central China Cardiovascular Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450007
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 211800
        • Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University)
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330038
        • Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Affilated Zhongshan Hospital of Dalian University
        • Contact:
      • Dalian, Liaoning, China
        • Frist Aiffiliated Hospital of Dalian Medical University
        • Contact:
    • Lilin
      • Changchun, Lilin, China, 130033
        • China-Japan Union Hospital of Jilin University
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
        • Contact:
      • Qingdao, Shandong, China
        • Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital)
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610031
        • The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Renal artery diameter stenosis ≥60%;
  2. Office systolic blood pressure ≥ 160 mmHg and/or office diastolic blood pressure ≥ 100 mmHg on at least two separate days without antihypertensive medication, or office systolic blood pressure ≥ 140 mmHg and/or office diastolic blood pressure ≥ 90 mmHg while on three antihypertensive drugs at conventional doses;
  3. Serum creatinine < 264 μmol/L (3.0 mg/dL);
  4. Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;

Exclusion Criteria:

  1. Unstable clinical condition rendering the patient intolerant to revascularisation therapy;
  2. Urinary protein ≥2+;
  3. Contrast medium allergy;
  4. Renal artery anatomy unsuitable for revascularisation therapy;
  5. Reference vessel diameter <3.5mm or >8mm.
  6. Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis);
  7. Reference vessel diameter < 3.5 mm or > 8 mm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stent group with FFR ≥ 0.8
Drug-induced hyperemic FFR ≥ 0.80
Device: Randomized to stenting
Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation.
Active Comparator: drug group with FFR ≥ 0.8
Drug-induced hyperemic FFR ≥0.80
Drug: Randomized to optimal medical therapy (OMT)
Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.
Other: FFR < 0.8
Drug-induced hyperemic FFR ≥0.80
Device: stent implantation
Patients with pharmacologically induced renal FFR < 0.80 will receive stent implantatio.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eGFR changes
Time Frame: From baseline to 12 months post-procedure
The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline.
From baseline to 12 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24h-SBP changes
Time Frame: From baseline to 12 months post-procedure
24-hour average systolic blood pressure
From baseline to 12 months post-procedure
24h-DBP changes
Time Frame: From baseline to 12 months post-procedure
24-hour average diastolic blood pressure
From baseline to 12 months post-procedure
OBP changes
Time Frame: From baseline to 12 months post-procedure
Change in Office Blood Pressure(OBP) at 12 months post-procedure compared to baseline.
From baseline to 12 months post-procedure
medication load changes
Time Frame: From baseline to 12 months post-procedure
Change in antihypertensive medication load at 12 months post-procedure compared to baseline
From baseline to 12 months post-procedure
perioperative complications
Time Frame: From baseline to 30 days post-procedure
The perioperative complications for atherosclerotic renal artery stenosis includes: renal artery injury, thrombosis, restenosis, infection, aortic dissection.
From baseline to 30 days post-procedure
Vascular Complications
Time Frame: From baseline to 12 months post-procedure
Incidence of Vascular complications, including delayed bleeding, pseudoaneurysm, arteriovenous fistula, or femoral artery stenosis/occlusion requiring clinical intervention.
From baseline to 12 months post-procedure
renal adverse events
Time Frame: From baseline to 12 months post-procedure
Renal adverse events after surgery in patients with atherosclerotic renal artery stenosis may include acute kidney injury, progressive renal dysfunction, and the need for renal replacement therapy such as dialysis.
From baseline to 12 months post-procedure
RBR
Time Frame: From baseline to 12 months post-procedure
risk-benefit ratio
From baseline to 12 months post-procedure
all-cause death
Time Frame: From baseline to 12 months post-procedure
Occurrence of death from any cause during the study period
From baseline to 12 months post-procedure
cardiovascular death
Time Frame: From baseline to 12 months post-procedure
From baseline to 12 months post-procedure
UACR changes
Time Frame: From baseline to 12 months post-procedure
urinary microalbumin-to-creatinine ratio (UACR)
From baseline to 12 months post-procedure
Rate of stent restenosis
Time Frame: From baseline to 12 months post-procedure
Rate of stent restenosis after stent implantation in patients with atherosclerotic renal artery stenosis.
From baseline to 12 months post-procedure
Rate of Renal Target Organ Damage
Time Frame: From baseline to 12 months post-procedure
sustained eGFR decline, CKD stage progression, new-onset overt proteinuria, kidney atrophy progression, initiation of kidney replacement therapy, or kidney-related hospitalization
From baseline to 12 months post-procedure
Number of Participants with myocardial infarction
Time Frame: From baseline to 12 months post-procedure
From baseline to 12 months post-procedure
Number of Participants with non-fatal stroke
Time Frame: From baseline to 12 months post-procedure
From baseline to 12 months post-procedure
Number of Participants with rehospitalization for congestive heart failure
Time Frame: From baseline to 12 months post-procedure
From baseline to 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

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 Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026-3057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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