Clinical Research Directory

A Placebo-controlled Trial of Fractional Flow Reserve-guided Percutaneous Renal Artery Stenting Among Atherosclerosis Renal-vascular Hypertension Patients

Objective: To determine whether percutaneous renal artery stenting guided by fractional flow reserve (FFR), in addition to standard medical therapy, provides superior therapeutic efficacy compared to medical therapy alone in patients with atherosclerotic renal artery stenosis and hypertension. Study Design: A double-blind, multicenter, prospective, randomized, placebo-controlled (sham procedure) trial. Primary Endpoint: The percentage reduction in daytime mean systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) from baseline to 3 months after the procedure. Study Population: A total of 200 patients who are potential candidates for renal artery intervention will be enrolled. Participants must meet all of the following inclusion criteria to be eligible for the study. Participant Screening and Enrollment: Once a patient is preliminarily assessed in the outpatient clinic and meets the clinical inclusion/exclusion criteria, written informed consent will be obtained, and the patient will enter a 1-week screening period. During this period, patients will perform home blood pressure monitoring using a calibrated Bluetooth-enabled device provided by the study team, which automatically uploads data. In addition, antihypertensive medications will be standardized to optimize blood pressure management. If home BP measurements during the screening period continue to meet inclusion criteria, baseline ABPM will be conducted. Following standardized renal angiography, patients whose renal anatomy meets the angiographic inclusion/exclusion criteria will undergo functional assessment of the stenotic lesion using a pressure wire and measurement of renal fractional flow reserve (FFR) under dopamine-induced maximal hyperemia, in accordance with the Standard Operating Procedure (SOP). Patients who qualify will then be randomized based on FFR results using an Interactive Response Technology (IRT) system. All eligible patients will be assigned a unique subject identification number during screening, and randomization will occur on the day of angiography, ensuring allocation concealment and unbiased group assignment. Study Intervention: Eligible participants who meet all inclusion and exclusion criteria will undergo renal angiography. On the day of angiography, a functional assessment of renal artery stenosis will be performed according to the Standard Operating Procedure (SOP) using a pressure wire under dopamine-induced maximal hyperemia to measure the Fractional Flow Reserve (FFR). * If FFR ≥ 0.80, no renal artery stenting will be performed. * If FFR \< 0.80, participants will be randomized in a 1:1 ratio to one of the following two intervention arms: * Stenting Group: Renal artery stenting * Control Group: Sham procedure The randomization assignment will be blinded to participants and follow-up investigators. Only designated study investigators and the operating team will be aware of the group allocation. For participants randomized to the sham procedure, the procedure will last at least 15 minutes to simulate actual intervention according to SOP guidelines. Group allocation will remain blinded until the primary endpoint is assessed at 3 months post-procedure. All participants, regardless of group assignment, will receive guideline-directed optimized medical therapy throughout the study period. Study Duration and Follow-up: Participants will be followed for a total of 12 months with study visits scheduled at the following time points: * 4 weeks post-procedure (telephone visit) * 12 weeks (clinic visit) * 6 months (clinic visit) * 12 months (clinic visit) To minimize the impact of antihypertensive medication adjustments on statistical outcomes, it is strongly recommended that no changes be made to antihypertensive regimens during the first 3 months after enrollment unless clinically necessary, such as in cases of: * Systolic BP \< 100 mmHg, or * Systolic BP \> 180 mmHg and/or diastolic BP \> 100 mmHg. All changes to antihypertensive therapy (including drug type and dosage) will be documented in detail. To ensure consistency and quality, standardized recommendations for antihypertensive drug selection and adjustment will be provided in accordance with current hypertension management guidelines.

Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis

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.

Fractional Flow Reserve to Determine Atherosclerosis Renovascular Hypertension Stenting

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.