Atherosclerotic Renal Artery Stenosis, Hypertension, Renal Artery Stenosis
Conditions
Keywords
covered stents, bare metal stents, atherosclerotic renal artery stenosis
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.
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.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in eGFR | 12 months | Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-Hour Ambulatory Systolic Blood Pressure | 12 months | Change in 24-Hour Ambulatory Systolic Blood Pressure Compared With Baseline |
| Change in 24-Hour Ambulatory Diastolic Blood Pressure | 12 months | Change in 24-Hour Ambulatory Diastolic Blood Pressure Compared With Baseline |
| Change in Office Systolic Blood Pressure | 12 months | Change in Office Systolic Blood Pressure Compared With Baseline |
| Change in Office Diastolic Blood Pressure | 12 months | Change in Office Diastolic Blood Pressure Compared With Baseline |
| Change in Home Systolic Blood Pressure | 12 months | Change in Home Systolic Blood Pressure Compared With Baseline |
| Change in Home Diastolic Blood Pressure | 12 months | Change in Home Diastolic Blood Pressure Compared With Baseline |
| Change in antihypertensive medication burden | 12 months | Change in antihypertensive medication burden at 12 months compared with pre-procedure levels |
| Stent patency | 12 months | Stent patency at 12 months |
| Incidence of perioperative complications | 1 month | — |
| MACE | 12 months | Major adverse cardiovascular events (MACE) include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure. |
| Renal Adverse Events | 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. |
Countries
China
Contacts
CONTACTXiongjing Jiang
CONTACTHui Dong
Outcome results
None listed