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Endovascular Therapy for Renal Artery Stenosis in China (ETRAS-China)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03080519
Recruitment Status : Not yet recruiting
First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Condition or disease Intervention/treatment Phase
Renal Artery Obstruction Hypertension, Renovascular Procedure: Endovascular Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Intervational Therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Registry of Endovascular Therapy for Renal Artery Stenosis in China
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endovascular Therapy
Renal artery revascularization
Procedure: Endovascular Therapy
Balloon angioplasty and stenting for renal artery stenosis




Primary Outcome Measures :
  1. 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 ]
  2. 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 Outcome Measures :
  1. Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.) [ Time Frame: Perioperative period ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080519


Contacts
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Contact: Xiongjing Jiang, MD 86-1088322385 jxj103@hotmail.com
Contact: Hui Dong, MD 86-1088322387 donghui666@sina.com

Locations
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China, Beijing
Beijing Renhe Hospital
Beijing, Beijing, China, 010
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing, China, 010
Contact: Xiongjing Jiang, MD    86-1088322385    jxj103@hotmail.com   
China, Chongqing
Daping Hospital
Chongqing, Chongqing, China, 023
Contact: Zhigang Zhao, MD    86-023-68811229    zhaozgsir@126.com   
China, Gansu
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 0931
Contact: Jing Yu, MD    86-0931-8942262    yujing2304@126.com   
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 020
Contact: Jianfang Luo, MD    86-020-83827812    henryjfl@tom.com   
The Eighth Affiliated Hospital of Sun Yat-sen University
Shenzhen, Guangdong, China, 0755
Contact: Nan Jia, MD    86-0755-83982222    jiananchina@hotmail.com   
China, Heilongjiang
Hongqi Hospital
Mudanjiang, Heilongjiang, China, 0453
Contact: Tongqing Lu, MD    86-0453-6224739    lutongqing@hotmail.com   
China, Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 0791
Contact: Zeqi Zheng, MD    86-0791-88692748    zeqizheng@126.com   
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 0791
Contact: Ping Li, MD    86-0791-86297662    lipingsydney@163.com   
China, Liaoning
The General Hospital of Shenyang Military
Shenyang, Liaoning, China, 024
Contact: Xiaozeng Wang, MD    86-024-28886666    wxiaozeng@163.com   
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 021
Contact: Jianzhong Xu, MD    86-021-64370045    jianzhongxv@gmail.com   
China, Shanxi
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China, 0351
Contact: Bin Yang, MD    86-0351-5661145    yangbxys@163.com   
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi, China, 029
Contact: Hongyan Tian, MD    86-029-85252580    tianhhyy@mail.xjtu.edu.cn   
Xi'an NO.3 Hospital
Xi'an, Shanxi, China, 029
Contact: Kang Cheng, MD    86-029-61895566    chengkang2009@foxmail.com   
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 028
Contact: Xiaoping Chen, MD    86-028-85422114    chenxp13@aliyun.com   
China, Zhejiang
Zhejiang Hospital
Hangzhou, Zhejiang, China, 0571
Contact: Lijiang Tang, MD    86-0571-87987373    lxw_76@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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Principal Investigator: Xiongjing Jiang, Dr. Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

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Responsible Party: Xiongjing Jiang, Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03080519    
Other Study ID Numbers: 2017-ZX-0214
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital:
renal artery stenosis
balloon angioplasty
stents
Additional relevant MeSH terms:
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Renal Artery Obstruction
Hypertension, Renovascular
Constriction, Pathologic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Hypertension, Renal