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NCT Number: NCT07566065

Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 glomerular filtration rate (GFR) ≥ 10 mL/min;

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

Treatment and study plan

covered stent

Device

Endovascular implantation of a covered stent in the renal artery

Bare Metal Stent

Device

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

Primary outcomes

  1. Change in eGFR

    Time frame: 12 months

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

Secondary outcomes

  1. Change in 24-Hour Ambulatory Systolic Blood Pressure

    Time frame: 12 months

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

  2. Change in 24-Hour Ambulatory Diastolic Blood Pressure

    Time frame: 12 months

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

  3. Change in Office Systolic Blood Pressure

    Time frame: 12 months

    Change in Office Systolic Blood Pressure Compared With Baseline

  4. Change in Office Diastolic Blood Pressure

    Time frame: 12 months

    Change in Office Diastolic Blood Pressure Compared With Baseline

  5. Change in Home Systolic Blood Pressure

    Time frame: 12 months

    Change in Home Systolic Blood Pressure Compared With Baseline

  6. Change in Home Diastolic Blood Pressure

    Time frame: 12 months

    Change in Home Diastolic Blood Pressure Compared With Baseline

  7. Change in antihypertensive medication burden

    Time frame: 12 months

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

  8. Stent patency

    Time frame: 12 months

    Stent patency at 12 months

  9. Incidence of perioperative complications

    Time frame: 1 month

  10. MACE

    Time frame: 12 months

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

  11. Renal Adverse Events

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Dong

CONTACT

[email protected]

86-010-88322385

Xiongjing Jiang

CONTACT

[email protected]

86-010-88322387

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Endovascular Treatment of Atherosclerotic Renal Artery Stenosis: A Prospective Randomized Controlled Study Comparing Covered Stents and Bare Metal Stents

Acronym: COMBAT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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