Clinical trial NCT03080519: Endovascular Therapy for Renal Artery Stenosis in China
Official title: A Multicenter Registry of Endovascular Therapy for Renal Artery Stenosis in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Artery Obstruction
Hypertension, Renovascular
Keywords: renal artery stenosis
balloon angioplasty
stents
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervational Therapy
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy：Change in blood pressure compared to baseline
timeFrame: 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
measure: Safety: Change in estimated glomerular filtration rate compared to baseline
timeFrame: 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:
measure: Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.)
timeFrame: Perioperative period
measure: The incidence of major adverse event (cardiovascular or renal death,myocardial infarction,hospitalization for congestive heart failure, stroke, and renal failure)
timeFrame: 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
measure: The incidence of renal artery restenosis(>50%)
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Renhe Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Eighth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Mudanjiang
country: China
facility: Hongqi Hospital
state: Heilongjiang
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an NO.3 Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Xiongjing Jiang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: