Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Covered Stent, Bare Metal Stent.
- Who it may be relevant to
- Registry conditions: Atherosclerotic Renal Artery Stenosis, Hypertension, Renal Artery Stenosis. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endovascular Treatment of Atherosclerotic Renal Artery Stenosis: A Prospective Randomized Controlled Study Comparing Covered Stents and Bare Metal Stents
Overview
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.
Interventions
- Device Covered Stent
Endovascular implantation of a covered stent in the renal artery - Device Bare Metal Stent
Endovascular implantation of a bare metal stent in the renal artery.
Primary outcome measures
- Change in eGFR [Time frame: 12 months]
Secondary outcome measures (11)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 15 centers
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
- The Second Affiliated Hospital of Harbin Medical University — Harbin
- Fuwai Central China Cardiovascular Hospital — Zhengzhou
- Zhengzhou Central Hospital Affiliated to Zhengzhou University — Zhengzhou
- Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University) — Nanjing
- Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical Co — Nanchang
- Affilated Zhongshan Hospital of Dalian University — Dalian
- Frist Aiffiliated Hospital of Dalian Medical University — Dalian
- … and 7 more centers
Identifiers
NCT: NCT07566065 · 2026-0427