covered stent
DeviceEndovascular implantation of a covered stent in the renal artery
NCT Number: NCT07566065
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.
Trial opening soon.
Get Notified40 year–80 year
All sexes
Interventional
Not applicable
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Endovascular implantation of a covered stent in the renal artery
Endovascular implantation of a bare metal stent in the renal artery.
Time frame: 12 months
Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline
Time frame: 12 months
Change in 24-Hour Ambulatory Systolic Blood Pressure Compared With Baseline
Time frame: 12 months
Change in 24-Hour Ambulatory Diastolic Blood Pressure Compared With Baseline
Time frame: 12 months
Change in Office Systolic Blood Pressure Compared With Baseline
Time frame: 12 months
Change in Office Diastolic Blood Pressure Compared With Baseline
Time frame: 12 months
Change in Home Systolic Blood Pressure Compared With Baseline
Time frame: 12 months
Change in Home Diastolic Blood Pressure Compared With Baseline
Time frame: 12 months
Change in antihypertensive medication burden at 12 months compared with pre-procedure levels
Time frame: 12 months
Stent patency at 12 months
Time frame: 1 month
Time frame: 12 months
Major adverse cardiovascular events (MACE) include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure.
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.
Contact information is provided by the study sponsor or research team.
Hui Dong
CONTACT
Xiongjing Jiang
CONTACT
Chinese Academy of Medical Sciences, Fuwai Hospital
Other
Endovascular Treatment of Atherosclerotic Renal Artery Stenosis: A Prospective Randomized Controlled Study Comparing Covered Stents and Bare Metal Stents
Acronym: COMBAT
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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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