An interventional study of Randomized to stenting and stent implantation in Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve and Optimal Medical Therapy, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Recruiting at 20 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Treatment
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.
59 studies on the registry are indexed under Renal Artery Obstruction; 10 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 42 interventional studies indexed under Renal Artery Obstruction.
Browse Renal Artery Obstruction studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 147 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug-induced hyperemic FFR ≥ 0.80
Device: Randomized to stenting
Drug-induced hyperemic FFR ≥0.80
Drug: Randomized to optimal medical therapy (OMT)
Drug-induced hyperemic FFR ≥0.80
Device: stent implantation
Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation.
Patients with pharmacologically induced renal FFR \< 0.80 will receive stent implantatio.
Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.
eGFR changes
The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline.
Time frame: From baseline to 12 months post-procedure
24h-SBP changes
24-hour average systolic blood pressure
Time frame: From baseline to 12 months post-procedure
24h-DBP changes
24-hour average diastolic blood pressure
Time frame: From baseline to 12 months post-procedure
OBP changes
Change in Office Blood Pressure(OBP) at 12 months post-procedure compared to baseline.
Time frame: From baseline to 12 months post-procedure
medication load changes
Change in antihypertensive medication load at 12 months post-procedure compared to baseline
Time frame: From baseline to 12 months post-procedure
Rate of stent restenosis
Rate of stent restenosis after stent implantation in patients with atherosclerotic renal artery stenosis.
Time frame: From baseline to 12 months post-procedure
perioperative complications
The perioperative complications for atherosclerotic renal artery stenosis includes: renal artery injury, thrombosis, restenosis, infection, aortic dissection.
Time frame: From baseline to 30 days post-procedure
Vascular Complications
Incidence of Vascular complications, including delayed bleeding, pseudoaneurysm, arteriovenous fistula, or femoral artery stenosis/occlusion requiring clinical intervention.
Time frame: From baseline to 12 months post-procedure
renal adverse events
Renal adverse events after surgery in patients with atherosclerotic renal artery stenosis may include acute kidney injury, progressive renal dysfunction, and the need for renal replacement therapy such as dialysis.
Time frame: From baseline to 12 months post-procedure
Rate of Renal Target Organ Damage
sustained eGFR decline, CKD stage progression, new-onset overt proteinuria, kidney atrophy progression, initiation of kidney replacement therapy, or kidney-related hospitalization
Time frame: From baseline to 12 months post-procedure
RBR
risk-benefit ratio
Time frame: From baseline to 12 months post-procedure
all-cause death
Occurrence of death from any cause during the study period
Time frame: From baseline to 12 months post-procedure
cardiovascular death
Time frame: From baseline to 12 months post-procedure
Number of Participants with myocardial infarction
Time frame: From baseline to 12 months post-procedure
Number of Participants with non-fatal stroke
Time frame: From baseline to 12 months post-procedure
Number of Participants with rehospitalization for congestive heart failure
Time frame: From baseline to 12 months post-procedure
UACR changes
urinary microalbumin-to-creatinine ratio (UACR)
Time frame: From baseline to 12 months post-procedure
Plan to share: Yes
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Mar 2026 → May 2026, on Nov 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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