Hypertension, Renovascular, Renal Artery Obstruction
Conditions
Keywords
renal artery stenosis, balloon angioplasty, stents
Brief summary
A multicenter prospective registry planned to recruit more than 5 000 patients with renal artery stenosis was carried out in China. This primary purpose of this study was to evaluate the safety and efficacy of renal artery revascularization in the real world. The secondary purpose was to investigate the etiologic distribution of renal artery stenosis and optimize the indications for renal artery revascularization.
Detailed description
Currently,the endovascular therapy of renal artery stenosis (especially atherosclerotic) remains in dispute. Some randomized control trials published in recent years (including ASTRAL and CORAL trials) showed the lack of additional benefit for renal artery revascularization compared with sole medical therapy. However,these randomized control trials presented a number of limitations including low numbers of patients and non-stringent inclusion criteria. Given clinical medical practice entering the era of big data, the large-sample real-word studies would be more objective to answer some pending issues of randomized controlled trial.Therefore,a multicenter prospective registry planned to recruit more than 5 000 patients with renal artery stenosis was carried out. This primary purpose of this study was to evaluate the safety and efficacy of renal artery revascularization in the real world. The secondary purpose was to investigate the etiologic distribution of renal artery stenosis and optimize the indications for renal artery revascularization.
Interventions
PROCEDUREEndovascular Therapy
Balloon angioplasty and stenting for renal artery stenosis
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intervational Therapy
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 14 at the time of informed consent 2. Diameter reduction of renal artery or main branch of renal artery≥ 60%,and ≥2 of four following conditions met:1)systolic hyperemic pressure gradient \>20 mm Hg,2)captopril renoscitigraphy positive in the lesion side ,3)renin-angiotensin-aldosterone system significantly activated and 4)severe reduction (\>25%) of glomendar filtration rate in the lesion side 3. office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg while receiving 3 antihypertensive drugs,or office systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg without antihypertensive drugs 4. Serum creatinine level\<264umol/L 5. Length of ipsilateral kidney ≥7.0 cm and glomendar filtration rate ≥10 ml／min 6. Urine protein \<2+
Exclusion criteria
1. Unable to provide informed consent 2. Unstable condition and unable to tolerate interventional therapy 3. intolerance to antiplatelet drugs or contrast medium 4. vascular anatomy not suitable for endovascular therapy 5. Pregnant, nursing, or planning to be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy：Change in blood pressure compared to baseline | Measured at 1 month and every 6 months thereafter from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Safety: Change in estimated glomerular filtration rate compared to baseline | Measured at 1 month and every 6 months thereafter from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.) | Perioperative period |
| The incidence of major adverse event (cardiovascular or renal death,myocardial infarction,hospitalization for congestive heart failure, stroke, and renal failure) | Measured at 1 month and every 6 months thereafter from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| The incidence of renal artery restenosis(>50%) | Measured every 6 months from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
Countries
China
Contacts
Primary ContactXiongjing Jiang, MD
Backup ContactHui Dong, MD
Outcome results
None listed