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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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