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
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2023
CompletedFirst Posted
Study publicly available on registry
May 15, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 15, 2023
March 1, 2023
3 years
April 5, 2023
May 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Primary patency rate
uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
9 months
Study Arms (2)
DEB group
EXPERIMENTALpaclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China)
POB group
PLACEBO COMPARATORInterventions
intervention group: treated with drug eluting balloon（paclitaxel-coated balloon； Orchid, Acotec Scientific Holdings Limited, Beijing, China)； control group :treated with plain old balloon
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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: 37845604DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2023
First Posted
May 15, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 15, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share