Actively Recruiting
Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis
Led by Peking University First Hospital · Updated on 2024-08-16
200
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Although randomized trials have demonstrated there is no benefit of renal-artery stenting in addition to medical therapy for patients with atherosclerosis renal artery stenosis, many patients indeed gained benefit in daily practices after stenting, such as reduction in blood pressure and recovery in renal functions. One important gap is that there is no universal standard to determine whether to stent in these patients. Fraction Flow Reserve (FFR) has been studied for many year in chronic coronary heart disease and FFR-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone. Based on the primary finding of FAIR-pilot study (NCT05732077), FFR-guided renal artery stenting is practical. The overall purpose of the FAIR trial is to compare the clinical outcomes and safety of FFR-guided stenting plus optimal medical treatment (OMT) versus OMT alone in patients with renal-vascular hypertensive patients. With the 'all comers' design, participants met the inclusive/exclusive criteria will be enrolled, and hyperemic FFR induced by dopamine will be measured in all participants. If FFR is ≥0.80, patients will be treated with OMT alone and follow up. If FFR is \<0.80, participants will be randomized to stenting in the renal artery plus OMT or OMT alone on a 1:1 ratio. The blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring, all participants will be followed up for 1 year.
CONDITIONS
Official Title
Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recorded hypertension with daytime mean systolic blood pressure at least 135 mmHg or diastolic blood pressure at least 85 mmHg on 24-hour ambulatory monitoring while on two or more antihypertensive drugs
- Evidence of renal artery stenosis undergoing renal artery angiography
- Able to follow study protocol and give informed consent
- Renal artery angiography showing at least one main artery stenosis between 50% and 90% with diameter 4.0 mm or larger
You will not qualify if you...
- Systolic blood pressure 200 mmHg or higher and/or diastolic blood pressure 120 mmHg or higher at day of randomization
- Fibromuscular dysplasia or non-atherosclerotic renal artery stenosis
- Pregnancy or unknown pregnancy status in women of childbearing potential
- Participation in any drug or device trial during study period
- History of stroke, transient ischemic attack, or carotid artery stenosis 70% or more
- Major surgery, heart attack, or interventional therapy within 30 days before study entry
- Left ventricular ejection fraction less than 30%
- Life expectancy less than 1 year due to other serious conditions
- Allergy to contrast dye, aspirin, or clopidogrel
- Previous kidney transplant
- Prior renal artery bypass surgery or stenting
- Kidney size less than 8 cm by ultrasound
- Serum creatinine above 3.0 mg/dl on day of randomization
- Reference vessel size less than 4 mm or greater than 8 mm
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
Y
Yuxi Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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