Endovascular Therapy for Renal Artery Stenosis in China

Renal Artery Obstruction Clinical Trial

— ETRAS-China  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03080519
• Other study ID #: 2017-ZX-0214
• Status: Not yet recruiting
• Phase: N/A
• First received: March 2, 2017
• Last updated: March 14, 2017
• Start date: April 2017
• Est. completion date: April 2024

Study information

• Verified date: March 2017
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiongjing Jiang, MD
• Phone: 86-1088322385
• Email: jxj103[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The secondary purpose was to investigate the etiologic distribution of renal artery stenosis and optimize the indications for renal artery revascularization.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: April 2024
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Hypertension, Renovascular
• Renal Artery Obstruction

Intervention

Procedure:
• Endovascular Therapy
Balloon angioplasty and stenting for renal artery stenosis

Locations

Country	Name	City	State
China	Beijing Renhe Hospital	Beijing	Beijing
China	Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Daping Hospital	Chongqing	Chongqing
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Hongqi Hospital	Mudanjiang	Heilongjiang
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The General Hospital of Shenyang Military	Shenyang	Liaoning
China	The Eighth Affiliated Hospital of Sun Yat-sen University	Shenzhen	Guangdong
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xi'an NO.3 Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.)		Perioperative period
Secondary	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
Secondary	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