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

March 14, 2017 updated by: Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010
        • Beijing Renhe Hospital
      • Beijing, Beijing, China, 010
        • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Chongqing
      • Chongqing, Chongqing, China, 023
        • Daping Hospital
    • Gansu
      • Lanzhou, Gansu, China, 0931
        • Lanzhou University Second Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 020
        • Guangdong General Hospital
      • Shenzhen, Guangdong, China, 0755
        • The Eighth Affiliated Hospital of Sun Yat-Sen University
    • Heilongjiang
      • Mudanjiang, Heilongjiang, China, 0453
    • Jiangxi
      • Nanchang, Jiangxi, China, 0791
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 0791
        • The Second Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China, 024
        • The General Hospital of Shenyang Military
    • Shanghai
      • Shanghai, Shanghai, China, 021
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China, 0351
        • Shanxi Cardiovascular Hospital
      • Xi'an, Shanxi, China, 029
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shanxi, China, 029
        • Xi'an No.3 Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 028
        • West China Hospital of Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 0571
        • Zhejiang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Endovascular Therapy
Renal artery revascularization
Procedure: Endovascular Therapy
Balloon angioplasty and stenting for renal artery stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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

Outcome Measure
Time Frame
Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.)
Time Frame: Perioperative period
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Principal Investigator: Xiongjing Jiang, Dr., Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2017

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2024

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 14, 2017

First Posted (ACTUAL)

March 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-ZX-0214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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