Renal Artery ObstructionETRAS-ChinaNCT03080519
Endovascular Therapy for Renal Artery Stenosis in China
A study testing Endovascular Therapy in people with Renal Artery Obstruction and Hypertension, Renovascular, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 16 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Renal Artery Obstruction, Hypertension, Renovascular
- What is being tested?
- Endovascular Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 16 sitesChina
- Study dates
- Apr 2017to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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+
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Renhe Hospital
Beijing, Beijing Municipality, 010
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 010
Xiongjing Jiang, MD, 86-1088322385, jxj103@hotmail.com
West China Hospital of Sichuan University
Chengdu, Sichuan, 028
Xiaoping Chen, MD, 86-028-85422114, chenxp13@aliyun.com
Daping Hospital
Chongqing, Chongqing Municipality, 023
Zhigang Zhao, MD, 86-023-68811229, zhaozgsir@126.com
Guangdong General Hospital
Guangzhou, Guangdong, 020
Jianfang Luo, MD, 86-020-83827812, henryjfl@tom.com
Zhejiang Hospital
Hangzhou, Zhejiang, 0571
Lijiang Tang, MD, 86-0571-87987373, lxw_76@163.com
Lanzhou University Second Hospital
Lanzhou, Gansu, 0931
Jing Yu, MD, 86-0931-8942262, yujing2304@126.com
Hongqi Hospital
Mudanjiang, Heilongjiang, 0453
Tongqing Lu, MD, 86-0453-6224739, lutongqing@hotmail.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 0791
Zeqi Zheng, MD, 86-0791-88692748, zeqizheng@126.com
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 0791
Ping Li, MD, 86-0791-86297662, lipingsydney@163.com
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 021
Jianzhong Xu, MD, 86-021-64370045, jianzhongxv@gmail.com
The General Hospital of Shenyang Military
Shenyang, Liaoning, 024
Xiaozeng Wang, MD, 86-024-28886666, wxiaozeng@163.com
The Eighth Affiliated Hospital of Sun Yat-sen University
Shenzhen, Guangdong, 0755
Nan Jia, MD, 86-0755-83982222, jiananchina@hotmail.com
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 0351
Bin Yang, MD, 86-0351-5661145, yangbxys@163.com
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 029
Hongyan Tian, MD, 86-029-85252580, tianhhyy@mail.xjtu.edu.cn
Xi'an NO.3 Hospital
Xi’an, Shanxi, 029
Kang Cheng, MD, 86-029-61895566, chengkang2009@foxmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Endovascular Therapy
- Keywords
- renal artery stenosis, balloon angioplasty, stents
- Medical subject headings
- Renal Artery Obstruction, Hypertension, Renovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular TherapyProcedure or surgery
Balloon angioplasty and stenting for renal artery stenosis
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Therapy | Experimental | Renal artery revascularization Receives: Procedure: Endovascular Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy：Change in blood pressure compared to baseline
Measured: 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: 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.)
Measured: Perioperative period
The incidence of major adverse event (cardiovascular or renal death,myocardial infarction,hospitalization for congestive heart failure, stroke, and renal failure)
Measured: 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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startApr 2017 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery ObstructionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervational Therapy
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiongjing Jiang, Dr., Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080519
- Sponsor's protocol ID
- 2017-ZX-0214
- Acronym
- ETRAS-China
- Status last verified
- Mar 2017
- First submitted
- 2 Mar 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry of Endovascular Therapy for Renal Artery Stenosis in China
- ClinicalTrials.gov ID
- NCT03080519
- Acronym / sponsor ID
- ETRAS-China / 2017-ZX-0214
- Keywords
- renal artery stenosis, balloon angioplasty, stents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Apr 2017 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervational Therapy
| Arm | Type | Receives |
|---|---|---|
| Endovascular Therapy | Experimental | Procedure: Endovascular TherapyRenal artery revascularization |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular TherapyBalloon angioplasty and stenting for renal artery stenosis | Procedure or surgery | Endovascular Therapy |
Primary outcome
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
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
3 secondary outcomes
Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.)
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiongjing Jiang, Dr. principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Therapy in people with Renal Artery Obstruction and Hypertension, Renovascular, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiongjing Jiang, MD (86-1088322385, jxj103@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.