FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• eGFR changes [Срок оценки: From baseline to 12 months post-procedure]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 20 центров

• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) — Гуанчжоу
• The Second Affiliated Hospital of Harbin Medical University — Харбин
• The Second Affiliated Hospital of Harbin Medical University — Харбин
• Fuwai Central China Cardiovascular Hospital — Чжэнчжоу
• Zhengzhou Central Hospital Affiliated to Zhengzhou University — Чжэнчжоу
• Zhengzhou Central Hospital Affiliated to Zhengzhou University — Чжэнчжоу
• … и ещё 12 центров

Идентификаторы

NCT: NCT07511309 · 2026-3057

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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