FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis

NCT07511309 | Not Yet Recruiting DMC

• 1 other identifier: 2026-3057
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Fractional Flow Reserve; Optimal Medical Therapy; Atherosclerotic Renal Artery Stenosis; Stent Implantation

Keywords

Atherosclerotic Renal Artery Stenosis; Fractional Flow Reserve; Optimal Medical Therapy

Outcome Measures

Primary Outcomes (1)

• eGFR changes

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

  From baseline to 12 months post-procedure

Secondary Outcomes (16)

• 24h-SBP changes

  From baseline to 12 months post-procedure

• 24h-DBP changes

  From baseline to 12 months post-procedure

• OBP changes

  From baseline to 12 months post-procedure

• medication load changes

  From baseline to 12 months post-procedure

• Rate of stent restenosis

  From baseline to 12 months post-procedure

Study Arms (3)

stent group with FFR ≥ 0.8

EXPERIMENTAL

Drug-induced hyperemic FFR ≥ 0.80

Device: Randomized to stenting

drug group with FFR ≥ 0.8

ACTIVE COMPARATOR

Drug-induced hyperemic FFR ≥0.80

Drug: Randomized to optimal medical therapy (OMT)

FFR < 0.8

OTHER

Drug-induced hyperemic FFR ≥0.80

Device: stent implantation

Interventions

Randomized to stenting DEVICE

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

stent group with FFR ≥ 0.8

stent implantation DEVICE

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

FFR < 0.8

Randomized to optimal medical therapy (OMT) DRUG

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

drug group with FFR ≥ 0.8

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal artery diameter stenosis ≥60%;
• 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;
• Serum creatinine \< 264 μmol/L (3.0 mg/dL);
• Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (20)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510080, China

Location

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

Guangzhou, Guangdong, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

Location

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, 450007, China

Location

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

Nanjing, Jiangsu, 211800, China

Location

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

Nanchang, Jiangxi, 330038, China

Location

Affilated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

Location

Frist Aiffiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

China-Japan Union Hospital of Jilin University

Changchun, Lilin, 130033, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

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

Qingdao, Shandong, China

Location

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

Chengdu, Sichuan, 610031, China

Location

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100037, China

Location

Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

TianJin First Central Hospital

Tianjin, 300192, China

Location

Central Study Contacts

Xiongjing Jiang

CONTACT

86-010-88322387; jiangxiongjing@163.com

Hui Dong

CONTACT

86-010-88322385; donghui666@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR \< 0.8 all underwent stenting

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (20)