FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis
China300 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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.
What they're measuring
1
eGFR changes
Timeframe: From baseline to 12 months post-procedure
Trial details
NCT IDNCT07511309
SponsorChinese Academy of Medical Sciences, Fuwai Hospital