FFR-guided revascularization for atherosclerotic renal artery stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In patients with atherosclerotic renal artery stenosis, the trial compares FFR-guided decisions (stent vs. medical therapy) to medical therapy alone, following randomized allocation based on baseline FFR values. The design builds on coronary FFR data to see if similar benefits apply to renal arteries. Eligible participants have high-grade renal artery stenosis and hypertension, with preserved kidney function, and are assigned to stenting or optimal medical therapy depending on FFR thresholds. The trial is conducted at several centers in Guangzhou under the Chinese Academy of Medical Sciences, Fuwai Hospital. Outcomes focus on blood pressure control, kidney function, and safety of revascularization strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
  Guangzhou, Guangdong, China Recruiting
• The Second Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• The Second Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• Fuwai Central China Cardiovascular Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Xiongjing Jiang
• Email: jiangxiongjing@163.com
• Phone: 86-010-88322387

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.