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Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting (FAIR-Pilot)
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.
Details
| Lead sponsor | Peking University First Hospital |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 100 |
| Start date | Tue Jan 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Mar 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Renal Artery Stenosis Atherosclerotic
- Secondary Hypertension Renal Arterial
Interventions
- Dopamine
- Fractional Flow Reserve, Renal
- Renal artery stenting
Countries
China