FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis

NCT07511309 · tracked via the Priya Life Science China tracker

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Phase

Not applicable

Started

2026-03-31

Last updated

2026-04-30

Condition(s) studied

Atherosclerotic Renal Artery StenosisFractional Flow ReserveOptimal Medical TherapyStent Implantation

Investigational drug(s) / intervention(s)

Randomized to stentingstent implantationRandomized to optimal medical therapy (OMT)

Randomized to stenting: Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation.

stent implantation: Patients with pharmacologically induced renal FFR \< 0.80 will receive stent implantatio.

Randomized to optimal medical therapy (OMT): Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.

Study summary

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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

eGFR changes — From baseline to 12 months post-procedure
The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline.

Trial sites (20)

Facility	City	Region
The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)	Guangzhou	Guangdong
The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan
Zhengzhou Central Hospital Affiliated to Zhengzhou University	Zhengzhou	Henan
Zhengzhou Central Hospital Affiliated to Zhengzhou University	Zhengzhou	Henan
Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University)	Nanjing	Jiangsu
Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)	Nanchang	Jiangxi
Affilated Zhongshan Hospital of Dalian University	Dalian	Liaoning
Frist Aiffiliated Hospital of Dalian Medical University	Dalian	Liaoning
China-Japan Union Hospital of Jilin University	Changchun	Lilin
Qilu Hospital of Shandong University	Jinan	Shandong
Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital)	Qingdao	Shandong
The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China	Chengdu	Sichuan
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	China
Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University	Chongqing	China
Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	China
TianJin First Central Hospital	Tianjin	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07511309 on ClinicalTrials.gov ↗ ← All trials in China