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FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis

Study acronym: FARS
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Secondary endpoints revised (16)
    • Study title shortened, about 4 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07511309
Lead Sponsor Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions
(from sponsor)
Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy, Stent Implantation
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov