Endovascular Therapy for Renal Artery Stenosis in China

Overview

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.

Full Title of Study: “A Multicenter Registry of Endovascular Therapy for Renal Artery Stenosis in China”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2022

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

  • Procedure: Endovascular Therapy
    • Balloon angioplasty and stenting for renal artery stenosis

Arms, Groups and Cohorts

  • Experimental: Endovascular Therapy
    • Renal artery revascularization

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiongjing Jiang, Professor – Chinese Academy of Medical Sciences, Fuwai Hospital
  • Overall Official(s)
    • Xiongjing Jiang, Dr., Principal Investigator, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Overall Contact(s)
    • Xiongjing Jiang, MD, 86-1088322385, jxj103@hotmail.com

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