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

Primary Purpose

Renal Artery Obstruction, Hypertension, Renovascular

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endovascular Therapy
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Artery Obstruction focused on measuring renal artery stenosis, balloon angioplasty, stents

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Renhe Hospital
  • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Daping Hospital
  • Lanzhou University Second Hospital
  • Guangdong General Hospital
  • The Eighth Affiliated Hospital of Sun Yat-sen University
  • Hongqi Hospital
  • The First Affiliated Hospital of Nanchang University
  • The Second Affiliated Hospital of Nanchang University
  • The General Hospital of Shenyang Military
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Shanxi Cardiovascular Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Xi'an NO.3 Hospital
  • West China Hospital of Sichuan University
  • Zhejiang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular Therapy

Arm Description

Renal artery revascularization

Outcomes

Primary Outcome Measures

Efficacy：Change in blood pressure compared to baseline
Safety: Change in estimated glomerular filtration rate compared to baseline

Secondary Outcome Measures

Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.)
The incidence of major adverse event (cardiovascular or renal death,myocardial infarction,hospitalization for congestive heart failure, stroke, and renal failure)
The incidence of renal artery restenosis(>50%)

Full Information

First Posted
March 2, 2017
Last Updated
March 14, 2017
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03080519
Brief Title
Endovascular Therapy for Renal Artery Stenosis in China
Acronym
ETRAS-China
Official Title
A Multicenter Registry of Endovascular Therapy for Renal Artery Stenosis in China
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Obstruction, Hypertension, Renovascular
Keywords
renal artery stenosis, balloon angioplasty, stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervational Therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovascular Therapy
Arm Type
Experimental
Arm Description
Renal artery revascularization
Intervention Type
Procedure
Intervention Name(s)
Endovascular Therapy
Intervention Description
Balloon angioplasty and stenting for renal artery stenosis
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.)
Time Frame
Perioperative period
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 14 at the time of informed consent 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 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 Serum creatinine level<264umol/L Length of ipsilateral kidney ≥7.0 cm and glomendar filtration rate ≥10 ml／min Urine protein <2+ Exclusion Criteria: Unable to provide informed consent Unstable condition and unable to tolerate interventional therapy intolerance to antiplatelet drugs or contrast medium vascular anatomy not suitable for endovascular therapy Pregnant, nursing, or planning to be pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiongjing Jiang, MD
Phone
86-1088322385
Email
jxj103@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Dong, MD
Phone
86-1088322387
Email
donghui666@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiongjing Jiang, Dr.
Organizational Affiliation
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Renhe Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
010
Country
China
Facility Name
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
010
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiongjing Jiang, MD
Phone
86-1088322385
Email
jxj103@hotmail.com
Facility Name
Daping Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
023
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Zhao, MD
Phone
86-023-68811229
Email
zhaozgsir@126.com
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
0931
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Yu, MD
Phone
86-0931-8942262
Email
yujing2304@126.com
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
020
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfang Luo, MD
Phone
86-020-83827812
Email
henryjfl@tom.com
Facility Name
The Eighth Affiliated Hospital of Sun Yat-sen University
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
0755
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Jia, MD
Phone
86-0755-83982222
Email
jiananchina@hotmail.com
Facility Name
Hongqi Hospital
City
Mudanjiang
State/Province
Heilongjiang
ZIP/Postal Code
0453
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongqing Lu, MD
Phone
86-0453-6224739
Email
lutongqing@hotmail.com
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
0791
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeqi Zheng, MD
Phone
86-0791-88692748
Email
zeqizheng@126.com
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
0791
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Li, MD
Phone
86-0791-86297662
Email
lipingsydney@163.com
Facility Name
The General Hospital of Shenyang Military
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
024
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozeng Wang, MD
Phone
86-024-28886666
Email
wxiaozeng@163.com
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhong Xu, MD
Phone
86-021-64370045
Email
jianzhongxv@gmail.com
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
0351
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Yang, MD
Phone
86-0351-5661145
Email
yangbxys@163.com
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyan Tian, MD
Phone
86-029-85252580
Email
tianhhyy@mail.xjtu.edu.cn
Facility Name
Xi'an NO.3 Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Cheng, MD
Phone
86-029-61895566
Email
chengkang2009@foxmail.com
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
028
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Chen, MD
Phone
86-028-85422114
Email
chenxp13@aliyun.com
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
0571
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijiang Tang, MD
Phone
86-0571-87987373
Email
lxw_76@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Endovascular Therapy for Renal Artery Stenosis in China

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