An interventional study of Endovascular Therapy in Renal Artery Obstruction and Hypertension, Renovascular, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown at 16 sites in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2017-03-15.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Renal Artery Obstruction; 8 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 100 across 41 interventional studies indexed under Renal Artery Obstruction.
Browse Renal Artery Obstruction studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Renal artery revascularization
Procedure: Endovascular Therapy
Balloon angioplasty and stenting for renal artery stenosis
Efficacy：Change in blood pressure compared to baseline
Time frame: 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
Time frame: 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
Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.)
Time frame: Perioperative period
The incidence of major adverse event (cardiovascular or renal death,myocardial infarction,hospitalization for congestive heart failure, stroke, and renal failure)
Time frame: 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%)
Time frame: 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
Plan to share: No
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This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences, Fuwai Hospital