Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study
NCT ID: NCT05858190
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2023-06-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DEB group
paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China)
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
POB group
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
45 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Central Contacts
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yuexin chen, MD
Role: CONTACT
References
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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.
Other Identifiers
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HS - 2133
Identifier Type: -
Identifier Source: org_study_id
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