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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05858190

Enrollment

Registered

2023-05-15

Start date

2023-06-01

Completion date

2026-12-01

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Renovascular

Brief summary

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.

Interventions

PROCEDUREParallel Assignment

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Primary patency rate	9 months	uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass

Contacts

Primary Contactxitao song, MD

sxitao@sina.com96-10-69152501

Backup Contactyuexin chen, MD

96-10-69152502

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026