Renal Artery Stenosis AtheroscleroticFAIRNCT07111442
A Placebo-controlled Trial of Fractional Flow Reserve-guided Percutaneous Renal Artery Stenting Among Atherosclerosis Renal-vascular Hypertension Patients
A study testing renal artery fractional flow reserve measurement, dopamine and renal artery stent in people with Renal Artery Stenosis Atherosclerotic and Secondary Hypertension Renal Arterial, run by Peking University First Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Artery Stenosis Atherosclerotic, Secondary Hypertension Renal Arterial
- What is being tested?
- renal artery fractional flow reserve measurement, dopamine and renal artery stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2025to 30 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 years or older.
- Documented history of hypertension and currently taking two or more antihypertensive medications with uncontrolled blood pressure (defined as daytime systolic BP ≥135 mmHg and/or diastolic BP ≥85 mmHg on optimized medication therapy, as measured by baseline ABPM).
- Clinical evidence suggestive of renal artery stenosis, and scheduled for renal angiography.
- Willing and able to provide written informed consent prior to initiation of any study-related procedures, and willing to comply with all study requirements.
- Renal angiography shows ≥70% to <99% stenosis in at least one main renal artery with a reference vessel diameter of ≥4.0 mm.
Who cannot join
- Systolic BP ≥200 mmHg and/or diastolic BP ≥120 mmHg on the day of randomization.
- Suspected non-atherosclerotic causes of RAS, such as fibromuscular dysplasia or large-vessel vasculitis.
- Pregnant or breastfeeding women.
- Participation in another clinical trial that, in the investigator's opinion, could interfere with this study.
- Stroke or TIA within 3 months and known ≥70% carotid artery stenosis.
- Major surgery, myocardial infarction, or any interventional procedure within the past 30 days.
Show all 14Show fewer
- Known LVEF <30%.
- Life expectancy ≤1 year.
- Known allergy to contrast media or to any of the following medications: aspirin, clopidogrel.
- History of renal transplantation.
- Prior renal artery stenting or bypass surgery.
- Affected kidney length <8 cm on Doppler ultrasound.
- Serum creatinine >3.0 mg/dL (265.2 μmol/L) at baseline visit (measured by local laboratory).
- Reference vessel diameter <4 mm or >8 mm on angiography.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yuxi Li, MD, 00861083572283, liyuxi@bjmu.edu.cn
Jianping Li, MD
About this study
Official title: Fractional Flow Reserve-guided Percutaneous Renal Artery Stenting Versus Sham Procedure In Atherosclerosis Renal-vascular Hypertension Patients: a Double-blinded Multicenter Randomized Placebo-control Trial
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.
Read more
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.
- Being tested
- renal artery fractional flow reserve measurement, dopamine, renal artery stent, sham stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal artery fractional flow reserve measurementDiagnostic test
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).
dopamineDrug
Administer dopamine at 50 µg/kg via the renal artery to induce hyperemic.
renal artery stentDevice
Stent will be treated for the stenotic renal artery for patients randomized to stenting group
sham stentingOther
For participants randomized to the sham procedure, the procedure will last at least 15 minutes to simulate actual intervention according to SOP guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Registry group | Other | If FFR ≥ 0.80, no renal artery stenting will be performed. Receives: Diagnostic Test: renal artery fractional flow reserve measurement; Drug: dopamine |
| Stenting group | Experimental | 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 tenting Receives: Diagnostic Test: renal artery fractional flow reserve measurement; Drug: dopamine; Device: renal artery stent |
| Control Group | Sham comparator | If FFR < 0.80, participants will be randomized in a 1:1 ratio to one of the following two intervention arms: Control Group: Sham procedure Receives: Diagnostic Test: renal artery fractional flow reserve measurement; Drug: dopamine; Other: sham stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage reduction in daytime mean systolic blood pressure measured by ambulatory blood pressure monitoring from baseline to 3 months post-procedure.
Measured: from baseline to three months after procedure
Secondary outcomes (8)
Percentage change in the composite index of antihypertensive medication use
Measured: from baseline to 3 months post-procedure
Percentage reduction in 24-hour/daytime/nighttime mean systolic blood pressure measured by ambulatory blood pressure monitoring
Measured: from baseline to 3 months post-procedure
Percentage reduction in systolic blood pressure measured by home blood pressure monitoring
Measured: from baseline to 3 months post-procedure
Percentage reduction in office systolic blood pressure
Measured: from baseline to 3 months post-procedure
Change in the number of antihypertensive medications
Measured: from baseline to 3 months post-procedure
Number of hypertensive emergencies
Measured: from baseline to 3 months post-procedure
Percentage reduction in daytime mean systolic blood pressure by ambulatory blood pressure monitoring
Measured: from baseline to 6 months post-procedure
Percentage reduction in daytime mean systolic blood pressure by ambulatory blood pressure monitoring
Measured: from baseline to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery Stenosis AtheroscleroticStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111442
- Sponsor's protocol ID
- 2022CR77V3.0
- Acronym
- FAIR
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Flow Reserve-guided Percutaneous Renal Artery Stenting Versus Sham Procedure In Atherosclerosis Renal-vascular Hypertension Patients: a Double-blinded Multicenter Randomized Placebo-control Trial
- ClinicalTrials.gov ID
- NCT07111442
- Acronym / sponsor ID
- FAIR / 2022CR77V3.0
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Registry group | Other | Diagnostic Test: renal artery fractional flow reserve measurement, Drug: dopamineIf FFR ≥ 0.80, no renal artery stenting will be performed. |
| Stenting group | Experimental | Diagnostic Test: renal artery fractional flow reserve measurement, Drug: dopamine, Device: renal artery stentIf FFR < 0.80, participants will be randomized in a 1:1 ratio to one of the following two intervention arms: Stenting Group: Renal artery tenting |
| Control Group | Sham comparator | Diagnostic Test: renal artery fractional flow reserve measurement, Drug: dopamine, Other: sham stentingIf FFR < 0.80, participants will be randomized in a 1:1 ratio to one of the following two intervention arms: Control Group: Sham procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged 18 years or older.
- Documented history of hypertension and currently taking two or more antihypertensive medications with uncontrolled blood pressure (defined as daytime systolic BP ≥135 mmHg and/or diastolic BP ≥85 mmHg on optimized medication therapy, as measured by baseline ABPM).
- Clinical evidence suggestive of renal artery stenosis, and scheduled for renal angiography.
- Willing and able to provide written informed consent prior to initiation of any study-related procedures, and willing to comply with all study requirements.
- Renal angiography shows ≥70% to <99% stenosis in at least one main renal artery with a reference vessel diameter of ≥4.0 mm.
Key exclusion criteria (14 listed)
- Systolic BP ≥200 mmHg and/or diastolic BP ≥120 mmHg on the day of randomization.
- Suspected non-atherosclerotic causes of RAS, such as fibromuscular dysplasia or large-vessel vasculitis.
- Pregnant or breastfeeding women.
- Participation in another clinical trial that, in the investigator's opinion, could interfere with this study.
- Stroke or TIA within 3 months and known ≥70% carotid artery stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal artery fractional flow reserve measurementEligible 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). | Diagnostic test | Control Group, Registry group, Stenting group |
| dopamineAdminister dopamine at 50 µg/kg via the renal artery to induce hyperemic. | Drug | Control Group, Registry group, Stenting group |
| renal artery stentStent will be treated for the stenotic renal artery for patients randomized to stenting group | Device | Stenting group |
| sham stentingFor participants randomized to the sham procedure, the procedure will last at least 15 minutes to simulate actual intervention according to SOP guidelines. | Other | Control Group |
Primary outcome
The percentage reduction in daytime mean systolic blood pressure measured by ambulatory blood pressure monitoring from baseline to 3 months post-procedure.
Time frame: from baseline to three months after procedure
8 secondary outcomes
Percentage change in the composite index of antihypertensive medication use
Time frame: from baseline to 3 months post-procedure
Percentage reduction in 24-hour/daytime/nighttime mean systolic blood pressure measured by ambulatory blood pressure monitoring
Time frame: from baseline to 3 months post-procedure
Percentage reduction in systolic blood pressure measured by home blood pressure monitoring
Time frame: from baseline to 3 months post-procedure
Percentage reduction in office systolic blood pressure
Time frame: from baseline to 3 months post-procedure
Change in the number of antihypertensive medications
Time frame: from baseline to 3 months post-procedure
Number of hypertensive emergencies
Time frame: from baseline to 3 months post-procedure
Percentage reduction in daytime mean systolic blood pressure by ambulatory blood pressure monitoring
Time frame: from baseline to 6 months post-procedure
Percentage reduction in daytime mean systolic blood pressure by ambulatory blood pressure monitoring
Time frame: from baseline to 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal artery fractional flow reserve measurement, dopamine and renal artery stent in people with Renal Artery Stenosis Atherosclerotic and Secondary Hypertension Renal Arterial, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuxi Li, MD (00861083572283, liyuxi@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage reduction in daytime mean systolic blood pressure measured by ambulatory blood pressure monitoring from baseline to 3 months post-procedure. (time frame: from baseline to three months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.