Endovascular Treatment of Atherosclerotic Renal Artery Stenosis: A Prospective Randomized Controlled Study Comparing Covered Stents and Bare Metal Stents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 15
- Primary Endpoint
- Change in eGFR
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
bare metal stents group
Intervention: Bare Metal Stent (Device)
covered stents group
Intervention: Covered Stent (Device)
Outcomes
Primary Outcomes
Change in eGFR
Time Frame: 12 months
Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline
Secondary Outcomes
- Change in 24-Hour Ambulatory Systolic Blood Pressure(12 months)
- Change in 24-Hour Ambulatory Diastolic Blood Pressure(12 months)
- Change in Office Systolic Blood Pressure(12 months)
- Change in Office Diastolic Blood Pressure(12 months)
- Change in Home Systolic Blood Pressure(12 months)
- Change in Home Diastolic Blood Pressure(12 months)
- Change in antihypertensive medication burden(12 months)
- Stent patency(12 months)
- Incidence of perioperative complications(1 month)
- MACE(12 months)
- Renal Adverse Events(12 months)
Investigators
Xiongjing Jiang
Chief Physician, Department of Cardiology
Chinese Academy of Medical Sciences, Fuwai Hospital