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Not yet recruitingNCT07566065COMBATUpdated May 4, 2026

Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis

An interventional study of Covered Stent and Bare Metal Stent in Atherosclerotic Renal Artery Stenosis, Hypertension and Renal Artery Stenosis, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Not yet recruiting at 15 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Atherosclerotic Renal Artery Stenosis
  • Hypertension
  • Renal Artery Stenosis

Keywords

  • covered stents
  • bare metal stents
  • atherosclerotic renal artery stenosis
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 147 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (GFR) ≥ 10 mL/min;

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    bare metal stents group

    Device: Bare Metal Stent

  • Experimental
    covered stents group

    Device: Covered Stent

Interventions

  • DeviceCovered Stent

    Endovascular implantation of a covered stent in the renal artery

  • DeviceBare Metal Stent

    Endovascular implantation of a bare metal stent in the renal artery.

06

What researchers measure

Primary outcomes

  1. Change in eGFR

    Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline

    Time frame: 12 months

Secondary outcomes

  1. Change in 24-Hour Ambulatory Systolic Blood Pressure

    Change in 24-Hour Ambulatory Systolic Blood Pressure Compared With Baseline

    Time frame: 12 months

  2. Change in 24-Hour Ambulatory Diastolic Blood Pressure

    Change in 24-Hour Ambulatory Diastolic Blood Pressure Compared With Baseline

    Time frame: 12 months

  3. Change in Office Systolic Blood Pressure

    Change in Office Systolic Blood Pressure Compared With Baseline

    Time frame: 12 months

  4. Change in Office Diastolic Blood Pressure

    Change in Office Diastolic Blood Pressure Compared With Baseline

    Time frame: 12 months

  5. Change in Home Systolic Blood Pressure

    Change in Home Systolic Blood Pressure Compared With Baseline

    Time frame: 12 months

  6. Change in Home Diastolic Blood Pressure

    Change in Home Diastolic Blood Pressure Compared With Baseline

    Time frame: 12 months

  7. Change in antihypertensive medication burden

    Change in antihypertensive medication burden at 12 months compared with pre-procedure levels

    Time frame: 12 months

  8. Stent patency

    Stent patency at 12 months

    Time frame: 12 months

  9. Incidence of perioperative complications

    Time frame: 1 month

  10. MACE

    Major adverse cardiovascular events (MACE) include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure.

    Time frame: 12 months

  11. 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.

    Time frame: 12 months

07

Study locations

15 sites
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07566065
Responsible party
Xiongjing Jiang (Chief Physician, Department of Cardiology, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
May 4, 2026
Start date
Apr 30, 2026 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
May 4, 2026

Study contacts

Xiongjing Jiang
Contact
jiangxiongjing@163.com
86-010-88322387
Hui Dong
Contact
donghui666@sina.com
86-010-88322385

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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