Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Drug-eluting Balloon and Plain Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis: a Randomized Controlled Study

Conditions
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Hypertension, Renovascular

Intervention / Treatment
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* Device: Angioplasty with paclitaxel eluting balloon
* Device: Angioplasty with plain old balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18y and 45y. with ≥ 60% stenosis in at least one renal artery. with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg). patients with no severe renal insufficiency (eGFR>30 ml/min, length of the kidney ≥ 7cm). Good compliance. with informed consent. Exclusion Criteria: With apparent atherosclerotic risk factors. With renal intervention or surgery history. With congenital anatomical anomaly. With severe renal insufficiency (length of the target kidney < 7cm, total eGFR<30ml/min, divided eGFR of the target kidney<8 ml/min) With contraindication for antiplatelet therapy. With severe cardiopulmonary insufficiency. Allergic to contrast medium Being pregnant or preparing for pregnancy With active cancer. Life expectancy < 12 month Without informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intervention group: treated with drug eluting balloon control group :treated with plain old balloon
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEB group<br>angioplasty with paclitaxel eluting balloon | Device: Angioplasty with paclitaxel eluting balloon<br>* The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon<br>|
| Placebo Comparator: POB group<br>Angioplasty with plain old balloon | Device: Angioplasty with plain old balloon<br>* Angioplasty with plain old balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Artery Obstruction, Takayasu Arteritis, Fibromuscular Dysplasia