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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    90
  • sponsor
    Peking Union Medical College Hospital
Updated on 24 January 2021

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.

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.

Details
Condition RENOVASCULAR HYPERTENSION
Treatment Angioplasty with plain old balloon, Angioplasty with paclitaxel eluting balloon
Clinical Study IdentifierNCT04366596
SponsorPeking Union Medical College Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 45 yrs?
Gender: Male or Female
Do you have RENOVASCULAR HYPERTENSION?
Do you have any of these conditions: Do you have RENOVASCULAR HYPERTENSION??
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
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