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

Peking Union Medical College Hospital90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypertension, Renovascular

Interventions

Angioplasty with paclitaxel eluting balloonDEVICE

The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon

Angioplasty with plain old balloonDEVICE

Angioplasty with plain old balloon

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age between 18y and 45y. 2. with ≥ 60% stenosis in at least one renal artery. 3. with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg). 4. patients with no severe renal insufficiency (eGFR\>30 ml/min, length of the kidney ≥ 7cm). 5. Good compliance. 6. with informed consent. Exclusion Criteria: 1. With apparent atherosclerotic risk factors. 2. With renal intervention or surgery history. 3. With congenital anatomical anomaly. 4. With severe renal insufficiency (length of the target kidney \< 7cm, total eGFR\<30ml/min, divided eGFR of the target kidney\<8 ml/min) 5. With contraindication for antiplatelet therapy. 6. With severe cardiopulmonary insufficiency. 7. Allergic to contrast medium 8. Being pregnant or preparing for pregnancy 9. With active cancer. 10. Life expectancy \< 12 month 11. Without informed consent.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 9 months

Primary patency rate

uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass

Time frame: 9 months

Secondary Outcomes

Technical success rate

No residual stenosis more than 50%

Time frame: immediately after intervention

complication rate

All complications occurring within 30 days or during the same hospitalization as the revascularization procedure

Time frame: within 30 days post-intervention

Bail-out stenting rate

Stent implanted after angioplasty for residual stenosis of dissection

Time frame: during the procedure

Clinical benefit rate

Time frame: 1, 3,6,12 months

primary patency rate

Time frame: 6,12 months

Renal function

eGFR (ml/min)

Central Contacts

Xitao Song, MD

CONTACT

96-10-69152501 sxitao@sina.com

Yuexin Chen, MD

CONTACT

96-10-69152502 cyuexin2007@163.com

Data from ClinicalTrials.gov

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