Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parallel Assignment.
- Who it may be relevant to
- Registry conditions: Hypertension, Renovascular. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Procedure Parallel 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
Primary outcome measures
- Primary patency rate [Time frame: 9 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Song X, Fu Y, Lai Z, Di X, Zeng R, Shao J, Ni L, Liu Z, Song X, Ye W, Liu C, Liu B, Zheng Y, Chen Y. Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis-a multi-center study. BMC Cardiovasc Disord. 2023 Oct 16;23(1):510. doi: 10.1186/s12872-023-03484-5. PMID 37845604
Identifiers
NCT: NCT05858190 · HS - 2133