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Efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis will be tested in this study. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon(POB). The primary endpoint is efficacy of blood pressure control.
Renal artery stenosis is common cause for hypertension in young people. It could be treated with open surgery or endovascular intervention. Open surgery has relatively high complication rate. Endovascular intervention is micro-invasive but with high restenosis rate. Drug eluting balloon(DEB) has been demonstrated to be effective for preventing restenosis in peripheral arteries. This study aims to test the efficacy of drug eluting balloon for non-atherosclerotic renal artery stenosis. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon. The primary endpoint is efficacy of blood pressure control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEB group | Experimental | angioplasty with paclitaxel eluting balloon |
|
| POB group | Placebo Comparator | Angioplasty with plain old balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angioplasty with paclitaxel eluting balloon | Device | The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit rate(cure or improvement of hypertension) | Cure: diastolic blood pressure <90 mm Hg and systolic blood pressure <140 mm Hg off antihypertensive medications. Improvement: diastolic blood pressure <90 mm Hg and/or systolic blood pressure <140 mm Hg on the same or reduced number of medications (or reduced number of defined daily doses as described by the World Health Organization ) or a reduction in diastolic blood pressure by at least 15 mm Hg on the same or reduced number of medications | 9 months |
| Primary patency rate | uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | No residual stenosis more than 50% | immediately after intervention |
| complication rate | All complications occurring within 30 days or during the same hospitalization as the revascularization procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xitao Song, MD | Contact | 96-10-69152501 | sxitao@sina.com | |
| Yuexin Chen, MD | Contact | 96-10-69152502 | cyuexin2007@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuehong Zheng, MD | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D006978 | Hypertension, Renovascular |
| D012078 | Renal Artery Obstruction |
| D013625 | Takayasu Arteritis |
| D005352 | Fibromuscular Dysplasia |
| ID | Term |
|---|---|
| D006977 | Hypertension, Renal |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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intervention group: treated with drug eluting balloon control group :treated with plain old balloon
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The patients are randomly allocated into intervention and control group. The investigator and outcomes assessor only kwow the random number. The participants will not be told the exact group that they were allocated.
| Angioplasty with plain old balloon | Device | Angioplasty with plain old balloon |
|
| within 30 days post-intervention |
| Bail-out stenting rate | Stent implanted after angioplasty for residual stenosis of dissection | during the procedure |
| Clinical benefit rate | 1, 3,6,12 months |
| primary patency rate | 6,12 months |
| Renal function | eGFR (ml/min) | 6,9,12 months |
| Renal function | serum Cr | 6,9,12 months |
| secondary patency rate | any procedure that restores patency after occlusion | 9, 12 months |
| Target lesion revascularization | either repeat percutaneous or surgical revascularization for a lesion anywhere within the angioplasty region or the 5-mm borders proximal or distal to angioplasty region | 9,12 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001157 | Arterial Occlusive Diseases |
| D001015 | Aortic Arch Syndromes |
| D001018 | Aortic Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |