Clinical Trial: Endovascular Therapy for Renal Artery Stenosis in China

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Multicenter Registry of Endovascular Therapy for Renal Artery Stenosis in China

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 Summary: 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.
Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Chinese Academy of Medical Sciences, Fuwai Hospital

Dates:
Date Received: March 2, 2017
Date Started: April 2017
Date Completion: April 2024
Last Updated: March 14, 2017
Last Verified: March 2017