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Not yet recruiting NCT07511309

FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis

No phase Interventional Atherosclerotic Renal Artery Stenosis Fractional Flow Reserve Optimal Medical Therapy Stent Implantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Randomized to stenting, stent implantation, Randomized to optimal medical therapy (OMT).
Who it may be relevant to
Registry conditions: Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy, Stent Implantation. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Device Randomized to stenting
    Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation.
  • Device stent implantation
    Patients with pharmacologically induced renal FFR \< 0.80 will receive stent implantatio.
  • Drug Randomized to optimal medical therapy (OMT)
    Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.

Primary outcome measures

  • eGFR changes [Time frame: From baseline to 12 months post-procedure]
Secondary outcome measures (12)
  • 24h-SBP changes [Time frame: From baseline to 12 months post-procedure]
  • 24h-DBP changes [Time frame: From baseline to 12 months post-procedure]
  • OBP changes [Time frame: From baseline to 12 months post-procedure]
  • medication load changes [Time frame: From baseline to 12 months post-procedure]
  • Rate of stent restenosis [Time frame: From baseline to 12 months post-procedure]
  • perioperative complications [Time frame: From baseline to 30 days post-procedure]
  • Vascular Complications [Time frame: From baseline to 12 months post-procedure]
  • renal adverse events [Time frame: From baseline to 12 months post-procedure]
  • Rate of Renal Target Organ Damage [Time frame: From baseline to 12 months post-procedure]
  • RBR [Time frame: From baseline to 12 months post-procedure]
  • all-cause death [Time frame: From baseline to 12 months post-procedure]
  • cardiovascular death [Time frame: From baseline to 12 months post-procedure]

Eligibility criteria

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.
  • Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis);
  • Reference vessel diameter < 3.5 mm or > 8 mm.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 20 centers
  • The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) — Guangzhou
  • The Second Affiliated Hospital of Harbin Medical University — Harbin
  • The Second Affiliated Hospital of Harbin Medical University — Harbin
  • Fuwai Central China Cardiovascular Hospital — Zhengzhou
  • Zhengzhou Central Hospital Affiliated to Zhengzhou University — Zhengzhou
  • Zhengzhou Central Hospital Affiliated to Zhengzhou University — Zhengzhou
  • … and 12 more centers

Identifiers

NCT: NCT07511309 · 2026-3057

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗