Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study
Not Applicable
Not yet recruiting
- Conditions
- Hypertension, Renovascular
- Registration Number
- NCT05858190
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary patency rate 9 months uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie paclitaxel's efficacy in drug-eluting balloons for non-atherosclerotic renal artery stenosis?
How does drug-eluting balloon (DEB) therapy compare to plain old balloon (POB) in long-term blood pressure control for renovascular hypertension?
Which biomarkers correlate with improved outcomes in patients treated with paclitaxel-coated DEB for non-atherosclerotic renal artery stenosis?
What are the safety profiles and adverse event management strategies for DEB versus POB in renovascular hypertension treatment?
Are there alternative drug-eluting balloon agents or combination therapies for non-atherosclerotic renal artery stenosis beyond paclitaxel?