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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Hypertension, Renovascular

Treatments: Procedure: Parallel Assignment

Study type: Interventional

Funder types: Other

Identifiers

NCT05858190

HS - 2133

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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
• With active cancer.
• Life expectancy < 12 month
• Without informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

DEB group

Experimental group

Description:

paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China)

Treatment:

Procedure: Parallel Assignment

POB group

Placebo Comparator group

Treatment:

Procedure: Parallel Assignment