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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPeking Union Medical College Hospital

About this trial

The study will test the efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis. The DEB (paclitaxel eluting balloon) will be used in the intervention group, while the plain old balloon(POB) will be used in the control group. The primary outcome is the effect of blood pressure control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Parallel Assignment

    Procedure/Surgery

    intervention group: treated with drug eluting balloon(paclitaxel-coated balloon; Orchid, Acotec Scientific Holdings Limited, Beijing, China); control group :treated with plain old balloon

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: DEB groupExperimental treatment 1 intervention
Group B: POB groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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