Comparison of Drug-eluting Balloon and Plain Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis: a Randomized Controlled Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hypertension, Renovascular
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Clinical benefit rate(cure or improvement of hypertension)
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Clinical benefit rate(cure or improvement of hypertension)
Time Frame: 9 months
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
Primary patency rate
Time Frame: 9 months
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
Secondary Outcomes
- Bail-out stenting rate(during the procedure)
- Renal function(6,9,12 months)
- Clinical benefit rate(1, 3,6,12 months)
- Technical success rate(immediately after intervention)
- complication rate(within 30 days post-intervention)
- primary patency rate(6,12 months)
- secondary patency rate(9, 12 months)
- Target lesion revascularization(9,12 months)