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NOT YET RECRUITING
NCT07511309
NA

FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis: A Randomized Controlled Trial

Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-03-31

Completion Date

2028-03-31

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DEVICE

Randomized to stenting

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

DEVICE

stent implantation

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

DRUG

Randomized to optimal medical therapy (OMT)

Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.

Locations (20)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, China

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, China

Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University)

Nanjing, Jiangsu, China

Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)

Nanchang, Jiangxi, China

Affilated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Frist Aiffiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

China-Japan Union Hospital of Jilin University

Changchun, Lilin, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital)

Qingdao, Shandong, China

The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China

Chengdu, Sichuan, China

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