UnknownPhase 3

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

China90 participantsStarted 2019-10-01

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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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

What they're measuring

Clinical benefit rate(cure or improvement of hypertension)

Timeframe: 9 months

Primary patency rate

Timeframe: 9 months

Trial details

NCT IDNCT04366596

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

Contact for this trial

Xitao Song, MD

96-10-69152501 sxitao@sina.com

View on ClinicalTrials.gov More Hypertension, Renovascular trials