Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Therapy | Experimental | Renal artery revascularization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Therapy | Procedure | Balloon angioplasty and stenting for renal artery stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Device or procedure related acute adverse events (renal artery dissection,renal artery perforation,bleeding,and etc.) | Perioperative period | |
| The incidence of major adverse event (cardiovascular or renal death,myocardial infarction,hospitalization for congestive heart failure, stroke, and renal failure) |
Not provided
Inclusion Criteria:
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+
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiongjing Jiang, MD | Contact | 86-1088322385 | jxj103@hotmail.com | |
| Hui Dong, MD | Contact | 86-1088322387 | donghui666@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiongjing Jiang, Dr. | Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Renhe Hospital | Beijing | Beijing Municipality | 010 | China | ||
| Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| D006978 | Hypertension, Renovascular |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Intervational Therapy
Not provided
Not provided
Not provided
Not provided
| 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 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 |
| Beijing |
| Beijing Municipality |
| 010 |
| China |
|
| Daping Hospital | Chongqing | Chongqing Municipality | 023 | China |
|
| Lanzhou University Second Hospital | Lanzhou | Gansu | 0931 | China |
|
| Guangdong General Hospital | Guangzhou | Guangdong | 020 | China |
|
| The Eighth Affiliated Hospital of Sun Yat-sen University | Shenzhen | Guangdong | 0755 | China |
|
| Hongqi Hospital | Mudanjiang | Heilongjiang | 0453 | China |
|
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 0791 | China |
|
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 0791 | China |
|
| The General Hospital of Shenyang Military | Shenyang | Liaoning | 024 | China |
|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 021 | China |
|
| Shanxi Cardiovascular Hospital | Taiyuan | Shanxi | 0351 | China |
|
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | 029 | China |
|
| Xi'an NO.3 Hospital | Xi’an | Shanxi | 029 | China |
|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 028 | China |
|
| Zhejiang Hospital | Hangzhou | Zhejiang | 0571 | China |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006977 | Hypertension, Renal |
| D006973 | Hypertension |