Endovascular Therapy for Renal Artery Stenosis in China
ETRAS-China
A Multicenter Registry of Endovascular Therapy for Renal Artery Stenosis in China
1 other identifier
interventional
5,000
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2017
CompletedFirst Posted
Study publicly available on registry
March 15, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMarch 15, 2017
March 1, 2017
5 years
March 2, 2017
March 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy：Change in blood pressure compared to baseline
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
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 Outcomes (3)
Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.)
Perioperative period
The incidence of major adverse event (cardiovascular or renal death,myocardial infarction,hospitalization for congestive heart failure, stroke, and renal failure)
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%)
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
Study Arms (1)
Endovascular Therapy
EXPERIMENTALRenal artery revascularization
Interventions
Balloon angioplasty and stenting for renal artery stenosis
Eligibility Criteria
You may qualify if:
- 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+
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Beijing Renhe Hospital
Beijing, Beijing Municipality, 010, China
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 010, China
Daping Hospital
Chongqing, Chongqing Municipality, 023, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 0931, China
Guangdong General Hospital
Guangzhou, Guangdong, 020, China
The Eighth Affiliated Hospital of Sun Yat-sen University
Shenzhen, Guangdong, 0755, China
Hongqi Hospital
Mudanjiang, Heilongjiang, 0453, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 0791, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 0791, China
The General Hospital of Shenyang Military
Shenyang, Liaoning, 024, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 021, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 0351, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 029, China
Xi'an NO.3 Hospital
Xi’an, Shanxi, 029, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 028, China
Zhejiang Hospital
Hangzhou, Zhejiang, 0571, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiongjing Jiang, Dr.
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 2, 2017
First Posted
March 15, 2017
Study Start
April 1, 2017
Primary Completion
April 1, 2022
Study Completion
April 1, 2024
Last Updated
March 15, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share