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

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.

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Key information

Conditions

Hypertension, Renovascular Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Renal Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parallel Assignment

Procedure

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

Primary outcomes

Primary patency rate

Time frame: 9 months

uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass

Study contacts

Contact information is provided by the study sponsor or research team.

xitao song, MD

CONTACT

[email protected]

96-10-69152501

yuexin chen, MD

CONTACT

96-10-69152502

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Comparison of Drug Eluting Balloon and Plain Old Balloon for the Treatment of Non-atherosclerotic Renal Artery Stenosis--A Protocol of a Multicenter Study

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: May 15, 2023
Registry last updated: May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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