Fractional Flow Reserve to Determine Atherosclerosis Renal Hypertension Stenting
Status:
Recruiting
Trial end date:
2024-12-08
Target enrollment:
Participant gender:
Summary
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. The goal of this clinical trial is to learn whether Fraction Flow Reserve (FFR) is
appropriate to determine stenting in hypertension patients with atherosclerosis renal artery
stenosis. The main questions it aims to answer are:
- Is it appropriate to use FFR to determine whether or not stenting for hypertension
patients with atherosclerosis renal artery stenosis?
- To provide detailed data supporting design of further trial, such as sample size
calculating, cut-off value for FFR in renal artery stenosis, etc.
Participants met the inclusive/exclusive criteria will be randomized to stenting or not in
the renal artery, then hyperemic FFR induced by dopamine will be measured in all
participants. If FFR is ≥0.80, randomization will be applied. If FFR is <0.80, randomization
will be ignored, and stenting will be performed as planned. 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.