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

N/ANot Yet RecruitingNCT07511309

Chinese Academy of Medical Sciences, Fuwai Hospital300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Atherosclerotic Renal Artery Stenosis Fractional Flow Reserve

Interventions

Randomized to stentingDEVICE

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

stent implantationDEVICE

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

Randomized to optimal medical therapy (OMT)DRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

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

...and 10 more locations

Outcomes

Primary Outcomes

eGFR changes

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