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ClinicalTrials.gov ID

NCT07511309

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

300Estimated

Last Update Posted

Apr 30, 2026Actual

Start Date

Mar 31, 2026Estimated

Primary Completion Date

May 31, 2027Estimated

Completion Date

Mar 31, 2028Estimated

Official Title

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

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.

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

• Randomized to stenting
• stent implantation
• Randomized to optimal medical therapy (OMT)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

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