Atherosclerotic Renal Artery StenosisCOMBATNCT07566065
Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis
A study testing Covered Stent and Bare Metal Stent in people with Atherosclerotic Renal Artery Stenosis and Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 15 sites in China.
Trial summary
Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension , increasing the risk of cardiovascular and kidney-related complications. Some small-scale studies have suggested that covered stents are effective and safe, but high-quality evidence from large-scale studies in atherosclerotic… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Atherosclerotic Renal Artery Stenosis, Hypertension, Renal Artery Stenosis
- What is being tested?
- Covered Stent and Bare Metal Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 15 sitesChina
- Study dates
- 30 Apr 2026to 30 Apr 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
- 1) Renal artery diameter stenosis ≥60%; 2) 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; 3) Serum creatinine < 264 μmol/L (3.0 mg/dL); 4) Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;
Who cannot join
- 1) Unstable clinical condition rendering the patient intolerant to revascularisation therapy; 2) Urinary protein ≥2+; 3) Contrast medium allergy; 4) Renal artery anatomy unsuitable for revascularisation therapy; 5) Reference vessel diameter <3.5mm or >8mm. 6)Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis); 7)Reference vessel diameter < 3.5 mm or > 8 mm
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037
Beijing
Hui Dong, 15810161393, donghui666@sina.com
The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu
Chengdu, Sichuan, 610031
Zhen Zhang, 13708042927, 31350377@qq.com
Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
Affilated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Frist Aiffiliated Hospital of Dalian Medical University
Dalian, Liaoning
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Wenhao Xia, 020-87755766, xiawhao@mail.sysu.edu.cn
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Zhiyu Shi, 18645056661, zhangshuoemail@163.com
The Second Affiliated Hospital of Harbin Medical University, Ha'erbin
Harbin
Shuo Zhang, 18645056661, zhangshuoemail@163.com
China-Japan Union Hospital of Jilin University, Changchun, Lilin
Jilin City, 130033
Yuquan He, 13944145413, liuxueyan@jlu.edu.cn
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)
Nanchang, Jiangxi, 330038
Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University)
Nanjing, Jiangsu, 211800
Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital)
Qingdao, Shandong
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, 450007
Shuhua Yu, 0371-67690941, 13613716677@139.com
About this study
Official title: Endovascular Treatment of Atherosclerotic Renal Artery Stenosis: A Prospective Randomized Controlled Study Comparing Covered Stents and Bare Metal Stents
Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension , increasing the risk of cardiovascular and kidney-related complications. Some small-scale studies have suggested that covered stents are effective and safe, but high-quality evidence from large-scale studies in atherosclerotic renal artery stenosis remains limited.
This study aims to evaluate whether covered stents are more effective than bare metal stents in patients with atherosclerotic renal artery stenosis. Eligible participants will be randomly assigned to receive either a covered stent or a bare metal stent. Patients will be followed for 12 months to assess Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
The results of this study may help improve treatment strategies and guide the selection of stent type for patients with this condition.
- Being tested
- Covered Stent, Bare Metal Stent
- Keywords
- covered stents, bare metal stents, atherosclerotic renal artery stenosis
- Medical subject headings
- Hypertension, Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covered StentDevice
Endovascular implantation of a covered stent in the renal artery
Bare Metal StentDevice
Endovascular implantation of a bare metal stent in the renal artery.
| Study group | Role | What they receive |
|---|---|---|
| bare metal stents group | Active comparator | Not described Receives: Device: Bare Metal Stent |
| covered stents group | Experimental | Not described Receives: Device: Covered Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eGFR
Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline
Measured: 12 months
Secondary outcomes (11)
Change in 24-Hour Ambulatory Systolic Blood Pressure
Change in 24-Hour Ambulatory Systolic Blood Pressure Compared With Baseline
Measured: 12 months
Change in 24-Hour Ambulatory Diastolic Blood Pressure
Change in 24-Hour Ambulatory Diastolic Blood Pressure Compared With Baseline
Measured: 12 months
Change in Office Systolic Blood Pressure
Change in Office Systolic Blood Pressure Compared With Baseline
Measured: 12 months
Change in Office Diastolic Blood Pressure
Change in Office Diastolic Blood Pressure Compared With Baseline
Measured: 12 months
Change in Home Systolic Blood Pressure
Change in Home Systolic Blood Pressure Compared With Baseline
Measured: 12 months
Change in Home Diastolic Blood Pressure
Change in Home Diastolic Blood Pressure Compared With Baseline
Measured: 12 months
Change in antihypertensive medication burden
Change in antihypertensive medication burden at 12 months compared with pre-procedure levels
Measured: 12 months
Stent patency
Stent patency at 12 months
Measured: 12 months
Incidence of perioperative complications
Measured: 1 month
MACE
Major adverse cardiovascular events (MACE) include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure.
Measured: 12 months
Renal Adverse Events
Renal adverse events include a sustained decline in renal function (≥30% decrease in eGFR from baseline confirmed on repeat measurement), doubling of serum creatinine, initiation of renal replacement therapy (dialysis or kidney transplantation), or progression to end-stage renal disease.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 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
- NCT07566065
- Sponsor's protocol ID
- 2026-0427
- Acronym
- COMBAT
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Atherosclerotic Renal Artery Stenosis: A Prospective Randomized Controlled Study Comparing Covered Stents and Bare Metal Stents
- ClinicalTrials.gov ID
- NCT07566065
- Acronym / sponsor ID
- COMBAT / 2026-0427
- Keywords
- covered stents, bare metal stents, atherosclerotic renal artery stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 May 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.
Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension , increasing the risk of cardiovascular and kidney-related complications. Some small-scale studies have suggested that covered stents are effective and safe, but high-quality evidence from large-scale studies in atherosclerotic renal artery stenosis remains limited.
This study aims to evaluate whether covered stents are more effective than bare metal stents in patients with atherosclerotic renal artery stenosis. Eligible participants will be randomly assigned to receive either a covered stent or a bare metal stent. Patients will be followed for 12 months to assess Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
The results of this study may help improve treatment strategies and guide the selection of stent type for patients with this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bare metal stents group | Active comparator | Device: Bare Metal Stent |
| covered stents group | Experimental | Device: Covered Stent |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Renal artery diameter stenosis ≥60%; 2) 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; 3) Serum creatinine < 264 μmol/L (3.0 mg/dL); 4) Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;
Key exclusion criteria (1 listed)
- 1) Unstable clinical condition rendering the patient intolerant to revascularisation therapy; 2) Urinary protein ≥2+; 3) Contrast medium allergy; 4) Renal artery anatomy unsuitable for revascularisation therapy; 5) Reference vessel diameter <3.5mm or >8mm. 6)Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis); 7)Reference vessel diameter < 3.5 mm or > 8 mm
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 |
|---|---|---|
| Covered StentEndovascular implantation of a covered stent in the renal artery | Device | covered stents group |
| Bare Metal StentEndovascular implantation of a bare metal stent in the renal artery. | Device | bare metal stents group |
Primary outcome
Change in eGFR
Time frame: 12 months
Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline
11 secondary outcomes
Change in 24-Hour Ambulatory Systolic Blood Pressure
Time frame: 12 months
Change in 24-Hour Ambulatory Diastolic Blood Pressure
Time frame: 12 months
Change in Office Systolic Blood Pressure
Time frame: 12 months
Change in Office Diastolic Blood Pressure
Time frame: 12 months
Change in Home Systolic Blood Pressure
Time frame: 12 months
Change in Home Diastolic Blood Pressure
Time frame: 12 months
Change in antihypertensive medication burden
Time frame: 12 months
Stent patency
Time frame: 12 months
Incidence of perioperative complications
Time frame: 1 month
MACE
Time frame: 12 months
Renal Adverse Events
Time frame: 12 months
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 4 May 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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covered Stent and Bare Metal Stent in people with Atherosclerotic Renal Artery Stenosis and Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 15 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 1 inclusion and 1 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Change in eGFR (time frame: 12 months). 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 4 May 2026.