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

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

NCT04366596•Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

October 1, 2019

Primary Completion Date

October 1, 2023

Completion Date

October 1, 2023

Last Updated

April 29, 2020

Enrollment

ESTIMATED participants

Conditions

Hypertension, Renovascular

Interventions

Angioplasty with paclitaxel eluting balloon

DEVICE

Angioplasty with plain old balloon

DEVICE

Contacts

Xitao Song, MD

CONTACT

96-10-69152501 sxitao@sina.com

Yuexin Chen, MD

CONTACT

96-10-69152502 cyuexin2007@163.com