FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

40 years - 80 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

300 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Single masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (20)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

20 locations

Study team and timeline

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study start

May 15, 2026 Actual

Primary completion

May 31, 2027 Estimated

Study completion

Mar 31, 2028 Estimated

First posted

Apr 6, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts