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For patients with atherosclerotic renal artery stenosis, the results of randomized controlled trials published in recent years have failed to demonstrate that renal artery stenting is superior to optimal medical therapy. However, these studies still have limitations.
Fractional flow reserve (FFR) has been extensively studied in coronary artery disease, and it has been established that FFR-guided revascularization is superior to both angiography-guided percutaneous coronary intervention and medical therapy alone. Whether FFR can guide interventional treatment in patients with renal artery stenosis and hypertension is currently a hot topic in the field of renal artery stenosis research.
Eligible patients meeting the inclusion criteria were enrolled. Pharmacologically induced FFR values were measured as the baseline. Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR < 0.8 underwent stent implantation. Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stent group with FFR ≥ 0.8 | Experimental | Drug-induced hyperemic FFR ≥ 0.80 |
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| drug group with FFR ≥ 0.8 | Active Comparator | Drug-induced hyperemic FFR ≥0.80 |
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| FFR < 0.8 | Other | Drug-induced hyperemic FFR ≥0.80 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Randomized to stenting | Device | Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation. |
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| Measure | Description | Time Frame |
|---|---|---|
| eGFR changes | The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline. | From baseline to 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 24h-SBP changes | 24-hour average systolic blood pressure | From baseline to 12 months post-procedure |
| 24h-DBP changes | 24-hour average 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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Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR < 0.8 all underwent stenting
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| stent implantation | Device | Patients with pharmacologically induced renal FFR < 0.80 will receive stent implantatio. |
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| Randomized to optimal medical therapy (OMT) | Drug | Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy. |
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| From baseline to 12 months post-procedure |
| OBP changes | Change in Office Blood Pressure(OBP) at 12 months post-procedure compared to baseline. | From baseline to 12 months post-procedure |
| medication load changes | Change in antihypertensive medication load at 12 months post-procedure compared to baseline | From baseline to 12 months post-procedure |
| Rate of stent restenosis | Rate of stent restenosis after stent implantation in patients with atherosclerotic renal artery stenosis. | From baseline to 12 months post-procedure |
| perioperative complications | The perioperative complications for atherosclerotic renal artery stenosis includes: renal artery injury, thrombosis, restenosis, infection, aortic dissection. | From baseline to 30 days post-procedure |
| Vascular Complications | Incidence of Vascular complications, including delayed bleeding, pseudoaneurysm, arteriovenous fistula, or femoral artery stenosis/occlusion requiring clinical intervention. | From baseline to 12 months post-procedure |
| renal adverse events | Renal adverse events after surgery in patients with atherosclerotic renal artery stenosis may include acute kidney injury, progressive renal dysfunction, and the need for renal replacement therapy such as dialysis. | From baseline to 12 months post-procedure |
| Rate of Renal Target Organ Damage | sustained eGFR decline, CKD stage progression, new-onset overt proteinuria, kidney atrophy progression, initiation of kidney replacement therapy, or kidney-related hospitalization | From baseline to 12 months post-procedure |
| RBR | risk-benefit ratio | From baseline to 12 months post-procedure |
| all-cause death | Occurrence of death from any cause during the study period | From baseline to 12 months post-procedure |
| cardiovascular death | From baseline to 12 months post-procedure |
| Number of Participants with myocardial infarction | From baseline to 12 months post-procedure |
| Number of Participants with non-fatal stroke | From baseline to 12 months post-procedure |
| Number of Participants with rehospitalization for congestive heart failure | From baseline to 12 months post-procedure |
| UACR changes | urinary microalbumin-to-creatinine ratio (UACR) | From baseline to 12 months post-procedure |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510080 | China |
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| Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) | Guangzhou | Guangdong | China |
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| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150086 | China |
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| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150086 | China |
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| Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan | 450000 | China |
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| Zhengzhou Central Hospital Affiliated to Zhengzhou University | Zhengzhou | Henan | 450000 | China |
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| Zhengzhou Central Hospital Affiliated to Zhengzhou University | Zhengzhou | Henan | 450007 | China |
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| Nanjing Pukou People's Hospital(Liangjiang Hospital Southeast University) | Nanjing | Jiangsu | 211800 | China |
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| Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College) | Nanchang | Jiangxi | 330038 | China |
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| Affilated Zhongshan Hospital of Dalian University | Dalian | Liaoning | 116001 | China |
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| Frist Aiffiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
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| China-Japan Union Hospital of Jilin University | Changchun | Lilin | 130033 | China |
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| Qilu Hospital of Shandong University | Jinan | Shandong | China |
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| Qingdao Hospital University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital) | Qingdao | Shandong | China |
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| The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China | Chengdu | Sichuan | 610031 | China |
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| Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | 100037 | China |
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| Department of Cardiovascular Medicine, Cardiovascular Research Center , The First Affiliated Hospital of Chongqing Medical University | Chongqing | 400016 | China |
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| Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | 200025 | China |
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| TianJin First Central Hospital | Tianjin | 300192 | China |
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