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Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension , increasing the risk of cardiovascular and kidney-related complications. Some small-scale studies have suggested that covered stents are effective and safe, but high-quality evidence from large-scale studies in atherosclerotic renal artery stenosis remains limited.
This study aims to evaluate whether covered stents are more effective than bare metal stents in patients with atherosclerotic renal artery stenosis. Eligible participants will be randomly assigned to receive either a covered stent or a bare metal stent. Patients will be followed for 12 months to assess Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
The results of this study may help improve treatment strategies and guide the selection of stent type for patients with this condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bare metal stents group | Active Comparator |
| |
| covered stents group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covered Stent | Device | Endovascular implantation of a covered stent in the renal artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in eGFR | Change in estimated glomerular filtration rate (eGFR) at 12 months compared with baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-Hour Ambulatory Systolic Blood Pressure | Change in 24-Hour Ambulatory Systolic Blood Pressure Compared With Baseline | 12 months |
| Change in 24-Hour Ambulatory Diastolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiongjing Jiang | Contact | 86-010-88322387 | jiangxiongjing@163.com | |
| Hui Dong | Contact | 86-010-88322385 | donghui666@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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| Bare Metal Stent | Device | Endovascular implantation of a bare metal stent in the renal artery. |
|
Change in 24-Hour Ambulatory Diastolic Blood Pressure Compared With Baseline
| 12 months |
| Change in Office Systolic Blood Pressure | Change in Office Systolic Blood Pressure Compared With Baseline | 12 months |
| Change in Office Diastolic Blood Pressure | Change in Office Diastolic Blood Pressure Compared With Baseline | 12 months |
| Change in Home Systolic Blood Pressure | Change in Home Systolic Blood Pressure Compared With Baseline | 12 months |
| Change in Home Diastolic Blood Pressure | Change in Home Diastolic Blood Pressure Compared With Baseline | 12 months |
| Change in antihypertensive medication burden | Change in antihypertensive medication burden at 12 months compared with pre-procedure levels | 12 months |
| Stent patency | Stent patency at 12 months | 12 months |
| Incidence of perioperative complications | 1 month |
| MACE | Major adverse cardiovascular events (MACE) include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure. | 12 months |
| Renal Adverse Events | Renal adverse events include a sustained decline in renal function (≥30% decrease in eGFR from baseline confirmed on repeat measurement), doubling of serum creatinine, initiation of renal replacement therapy (dialysis or kidney transplantation), or progression to end-stage renal disease. | 12 months |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150086 | China |
|
| Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan | 450000 | China |
| Zhengzhou Central Hospital Affiliated to Zhengzhou University | Zhengzhou | Henan | 450007 | China |
|
| Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University) | Nanjing | Jiangsu | 211800 | China |
| Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College) | Nanchang | Jiangxi | 330038 | China |
| Affilated Zhongshan Hospital of Dalian University | Dalian | Liaoning | 116001 | China |
| Frist Aiffiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital) | Qingdao | Shandong | China |
| The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu | Chengdu | Sichuan | 610031 | China |
|
| Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037 | Beijing | China |
|
| Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University | Chongqing | 400016 | China |
| The Second Affiliated Hospital of Harbin Medical University, Ha'erbin | Harbin | China |
|
| China-Japan Union Hospital of Jilin University, Changchun, Lilin | Jilin City | 130033 | China |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D012078 | Renal Artery Obstruction |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
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