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A Study on the Safety and Non-inferiority of a New Strategy for Interventional Treatment of Renal Artery Stenosis Based on Fractional Flow Reserve (FFR): A Multicenter Randomized Controlled Study

A Study on the Safety and Non-inferiority of a New Strategy for Interventional Treatment of Renal Artery Stenosis Based on Fractional Flow Reserve (FFR): A Multicenter Randomized Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104592
Enrollment
Unknown
Registered
2025-06-19
Start date
2025-05-14
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal artery stenosis

Interventions

In the control group, renal angiography stenosis was 70%-90%:Drug treatment
Intervention group (FFR evaluation group), renal angiography stenosis 50%-69%:Renal angiography and FFR measurements, renal artery stent release
In the control group, renal angiography stenosis was 50%-69%:Drug treatment
Intervention group (FFR evaluation group) renal angiography stenosis 70%-90%:Renal angiography and FFR measurements, renal artery stent release

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18-80; 2.Patients with atherosclerotic renal artery stenosis; 3.Renal artery angiography confirmed that renal artery stenosis is 50%-90%; 4.Patients willing to receive medical treatment and sign informed consent form; 5.Patients with hypertension (including severe hypertension, malignant hypertension, refractory hypertension, worsening hypertension or drug intolerance); 6.Patients with abnormal renal function and short-term decline in renal function on the affected side; Note: Among the above standards, conditions 1 to 4 must be met, and at least one of conditions 5 and 6 must be satisfied.

Exclusion criteria

Exclusion criteria: 1.Long diameter of the kidney =2+); 3.CT or MR shows that there are a large number of renal parenchymal areas without perfusion; 4.Glomerular filtration rate (GFR) =3.0 mg/dL; 6.Intrarenal artery resistance index >=0.8; 7.Congenital malformation of renal artery is not suitable for interventional treatment; 8.Severe cardiac insufficiency, contrast allergies, active infection, malignant tumors or life expectancy is less than the study period;

Design outcomes

Primary

MeasureTime frame
Blood Flow Reserve Fraction (FFR);Renal angiography stenosis degree;Related indicators of renal function, including single-renal glomerular filtration rate (GFR), improvement of single-renal blood flow perfusion, improvement of serum creatinine, cystatin, and 24-hour;24-hour dynamic blood pressure;

Secondary

MeasureTime frame
Follow-up blood pressure;

Countries

China

Contacts

Public ContactDehui Qian

The Second Affiliated Hospital of the Army Medical University

qiandehui@163.com+86 23 68755715

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026