Atherosclerotic Renal Artery StenosisFARSNCT07511309
FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis
A study testing Randomized to stenting, stent implantation and Randomized to optimal medical therapy (OMT) in people with Atherosclerotic Renal Artery Stenosis and Fractional Flow Reserve, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 20 sites in China.
Trial summary
For patients with atherosclerotic renal artery stenosis, the results of randomized controlled trials published in recent years have failed to demonstrate that renal artery stenting is superior to optimal medical therapy. However, these studies still have limitations. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy
- What is being tested?
- Randomized to stenting, stent implantation and Randomized to optimal medical therapy (OMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 20 sitesChina
- Study dates
- 15 May 2026to 31 Mar 2028
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal artery diameter stenosis ≥60%;
- Office systolic blood pressure ≥ 160 mmHg and/or office diastolic blood pressure ≥ 100 mmHg on at least two separate days without antihypertensive medication, or office systolic blood pressure ≥ 140 mmHg and/or office diastolic blood pressure ≥ 90 mmHg while on three antihypertensive drugs at conventional doses;
- Serum creatinine < 264 μmol/L (3.0 mg/dL);
- Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;
Who cannot join
- Unstable clinical condition rendering the patient intolerant to revascularisation therapy;
- Urinary protein ≥2+;
- Contrast medium allergy;
- Renal artery anatomy unsuitable for revascularisation therapy;
- Reference vessel diameter <3.5mm or >8mm.
- Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis);
- Reference vessel diameter < 3.5 mm or > 8 mm.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites, 20 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
Hui Dong, 15810161393, donghui666@sina.com
Xiongjing Jiang, MD
- Not yet recruiting
China-Japan Union Hospital of Jilin University
Changchun, Lilin, 130033
Yuquan He, 13944145413, liuxueyan@jlu.edu.cn
- Not yet recruiting
The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China
Chengdu, Sichuan, 610031
Zhen Zhang, 13708042927, 31350377@qq.com
- Not yet recruiting
Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
Jing Chang, 18983289612, 1584105002@qq.com
- Not yet recruiting
Affilated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Minglian Gong, 0411-62896223, gongml777@126.com
- Not yet recruiting
Frist Aiffiliated Hospital of Dalian Medical University
Dalian, Liaoning
Ying Zhang, 18098876188, zy114129@sina.com
- Not yet recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Wenhao Xia, 020-87755766, xiawhao@mail.sysu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510080
Huiyong Wang, 18925070836, wanghuiyong77803@163.com
- Not yet recruiting
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
Guangzhou, Guangdong
Yingqing Feng, 13602863389, fyq1819@163.com
Songyuan Feng, 19924358791, water6459531@foxmail.com
- Not yet recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Shuo Zhang, 18645056661, zhangshuoemail@163.com
- Not yet recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Zhiyu Shi, 18645056661, zhangshuoemail@163.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Peili Bu, 18560086596, bupeili@medmail.com.cn
- Not yet recruiting
Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)
Nanchang, Jiangxi, 330038
Haohang Ruan, 0791-87721036, 18979198329@163.com
- Not yet recruiting
Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University)
Nanjing, Jiangsu, 211800
Li Wang, 025-58532832, 1340748410@qq.com
- Not yet recruiting
Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital)
Qingdao, Shandong
Nan Jia, 17669783012, jiananchina@qq.com
- Not yet recruiting
Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Jianzhong Xu, 13761452329, jianzhongxv@outlook.com
- Not yet recruiting
TianJin First Central Hospital
Tianjin, 300192
Chengzhi Lu, 022-23629373, Lucz8@126.com
- Not yet recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
Qiuping Zhao, 0371-58681170, qiupingzhao@zzu.edu.cn
- Not yet recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, 450000
Shuhua Yu, 0371-67690941, 13613716677@139.com
- Not yet recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, 450007
Shuhua Yu, 0371-67690941, 13613716677@139.com
About this study
Official title: Fractional Flow Reserve-Guided Revascularization in Atherosclerotic Renal Artery Stenosis: A Randomized Controlled Trial
For patients with atherosclerotic renal artery stenosis, the results of randomized controlled trials published in recent years have failed to demonstrate that renal artery stenting is superior to optimal medical therapy. However, these studies still have limitations.
Fractional flow reserve (FFR) has been extensively studied in coronary artery disease, and it has been established that FFR-guided revascularization is superior to both angiography-guided percutaneous coronary intervention and medical therapy alone. Whether FFR can guide interventional treatment in patients with renal artery stenosis and hypertension is currently a hot topic in the field of renal artery stenosis research.
Eligible patients meeting the inclusion criteria were enrolled. Pharmacologically induced FFR values were measured as the baseline. Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR < 0.8 underwent stent implantation. Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
- Conditions
- Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy, Stent Implantation
- Being tested
- Randomized to stenting, stent implantation, Randomized to optimal medical therapy (OMT)
- Keywords
- Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized to stentingDevice
Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation.
stent implantationDevice
Patients with pharmacologically induced renal FFR < 0.80 will receive stent implantatio.
Randomized to optimal medical therapy (OMT)Drug
Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.
| Study group | Role | What they receive |
|---|---|---|
| stent group with FFR ≥ 0.8 | Experimental | Drug-induced hyperemic FFR ≥ 0.80 Receives: Device: Randomized to stenting |
| drug group with FFR ≥ 0.8 | Active comparator | Drug-induced hyperemic FFR ≥0.80 Receives: Drug: Randomized to optimal medical therapy (OMT) |
| FFR < 0.8 | Other | Drug-induced hyperemic FFR ≥0.80 Receives: Device: stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR changes
The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline.
Measured: From baseline to 12 months post-procedure
Secondary outcomes (16)
24h-SBP changes
24-hour average systolic blood pressure
Measured: From baseline to 12 months post-procedure
24h-DBP changes
24-hour average diastolic blood pressure
Measured: From baseline to 12 months post-procedure
OBP changes
Change in Office Blood Pressure(OBP) at 12 months post-procedure compared to baseline.
Measured: From baseline to 12 months post-procedure
medication load changes
Change in antihypertensive medication load at 12 months post-procedure compared to baseline
Measured: From baseline to 12 months post-procedure
Rate of stent restenosis
Rate of stent restenosis after stent implantation in patients with atherosclerotic renal artery stenosis.
Measured: From baseline to 12 months post-procedure
perioperative complications
The perioperative complications for atherosclerotic renal artery stenosis includes: renal artery injury, thrombosis, restenosis, infection, aortic dissection.
Measured: From baseline to 30 days post-procedure
Vascular Complications
Incidence of Vascular complications, including delayed bleeding, pseudoaneurysm, arteriovenous fistula, or femoral artery stenosis/occlusion requiring clinical intervention.
Measured: From baseline to 12 months post-procedure
renal adverse events
Renal adverse events after surgery in patients with atherosclerotic renal artery stenosis may include acute kidney injury, progressive renal dysfunction, and the need for renal replacement therapy such as dialysis.
Measured: From baseline to 12 months post-procedure
Rate of Renal Target Organ Damage
sustained eGFR decline, CKD stage progression, new-onset overt proteinuria, kidney atrophy progression, initiation of kidney replacement therapy, or kidney-related hospitalization
Measured: From baseline to 12 months post-procedure
RBR
risk-benefit ratio
Measured: From baseline to 12 months post-procedure
all-cause death
Occurrence of death from any cause during the study period
Measured: From baseline to 12 months post-procedure
cardiovascular death
Measured: From baseline to 12 months post-procedure
Number of Participants with myocardial infarction
Measured: From baseline to 12 months post-procedure
Number of Participants with non-fatal stroke
Measured: From baseline to 12 months post-procedure
Number of Participants with rehospitalization for congestive heart failure
Measured: From baseline to 12 months post-procedure
UACR changes
urinary microalbumin-to-creatinine ratio (UACR)
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 posted6 Apr 2026
- Study start15 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Renal Artery StenosisStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Model description
- Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR \< 0.8 all underwent stenting
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511309
- Sponsor's protocol ID
- 2026-3057
- Acronym
- FARS
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Flow Reserve-Guided Revascularization in Atherosclerotic Renal Artery Stenosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07511309
- Acronym / sponsor ID
- FARS / 2026-3057
- Conditions
- Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy, Stent Implantation
- Keywords
- Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 6 Apr 2026 (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.
For patients with atherosclerotic renal artery stenosis, the results of randomized controlled trials published in recent years have failed to demonstrate that renal artery stenting is superior to optimal medical therapy. However, these studies still have limitations.
Fractional flow reserve (FFR) has been extensively studied in coronary artery disease, and it has been established that FFR-guided revascularization is superior to both angiography-guided percutaneous coronary intervention and medical therapy alone. Whether FFR can guide interventional treatment in patients with renal artery stenosis and hypertension is currently a hot topic in the field of renal artery stenosis research.
Eligible patients meeting the inclusion criteria were enrolled. Pharmacologically induced FFR values were measured as the baseline. Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR < 0.8 underwent stent implantation. Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR < 0.8 all underwent stenting
| Arm | Type | Receives |
|---|---|---|
| stent group with FFR ≥ 0.8 | Experimental | Device: Randomized to stentingDrug-induced hyperemic FFR ≥ 0.80 |
| drug group with FFR ≥ 0.8 | Active comparator | Drug: Randomized to optimal medical therapy (OMT)Drug-induced hyperemic FFR ≥0.80 |
| FFR < 0.8 | Other | Device: stent implantationDrug-induced hyperemic FFR ≥0.80 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Renal artery diameter stenosis ≥60%;
- Office systolic blood pressure ≥ 160 mmHg and/or office diastolic blood pressure ≥ 100 mmHg on at least two separate days without antihypertensive medication, or office systolic blood pressure ≥ 140 mmHg and/or office diastolic blood pressure ≥ 90 mmHg while on three antihypertensive drugs at conventional doses;
- Serum creatinine < 264 μmol/L (3.0 mg/dL);
- Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;
Key exclusion criteria (7 listed)
- Unstable clinical condition rendering the patient intolerant to revascularisation therapy;
- Urinary protein ≥2+;
- Contrast medium allergy;
- Renal artery anatomy unsuitable for revascularisation therapy;
- Reference vessel diameter <3.5mm or >8mm.
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 |
|---|---|---|
| Randomized to stentingPatients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation. | Device | stent group with FFR ≥ 0.8 |
| stent implantationPatients with pharmacologically induced renal FFR < 0.80 will receive stent implantatio. | Device | FFR < 0.8 |
| Randomized to optimal medical therapy (OMT)Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy. | Drug | drug group with FFR ≥ 0.8 |
Primary outcome
eGFR changes
Time frame: From baseline to 12 months post-procedure
The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline.
16 secondary outcomes
24h-SBP changes
Time frame: From baseline to 12 months post-procedure
24h-DBP changes
Time frame: From baseline to 12 months post-procedure
OBP changes
Time frame: From baseline to 12 months post-procedure
medication load changes
Time frame: From baseline to 12 months post-procedure
Rate of stent restenosis
Time frame: From baseline to 12 months post-procedure
perioperative complications
Time frame: From baseline to 30 days post-procedure
Vascular Complications
Time frame: From baseline to 12 months post-procedure
renal adverse events
Time frame: From baseline to 12 months post-procedure
Rate of Renal Target Organ Damage
Time frame: From baseline to 12 months post-procedure
RBR
Time frame: From baseline to 12 months post-procedure
all-cause death
Time frame: From baseline to 12 months post-procedure
cardiovascular death
Time frame: From baseline to 12 months post-procedure
Number of Participants with myocardial infarction
Time frame: From baseline to 12 months post-procedure
Number of Participants with non-fatal stroke
Time frame: From baseline to 12 months post-procedure
Number of Participants with rehospitalization for congestive heart failure
Time frame: From baseline to 12 months post-procedure
UACR changes
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 2 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomized to stenting, stent implantation and Randomized to optimal medical therapy (OMT) in people with Atherosclerotic Renal Artery Stenosis and Fractional Flow Reserve, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 20 sites 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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. 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 Xiongjing Jiang (86-010-88322387, jiangxiongjing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR changes (time frame: From baseline to 12 months post-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 2 Nov 2026.