NCT05858190Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 15 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 5 Apr 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- High blood pressure
- NCT number
- NCT05858190
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 1 Jun 2023 to the primary completion date, 1 Jun 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- With renal intervention or surgery history.
- With contraindication for antiplatelet therapy.
Other illness
- With severe renal insufficiency (length of the target kidney \< 7cm, total
- With severe cardiopulmonary insufficiency.
- Allergic to contrast medium
- With active cancer.
Lab values
- eGFR\<30ml/min, divided eGFR of the target kidney\<8 ml/min)
Other
- With apparent atherosclerotic risk factors.
- With congenital anatomical anomaly.
- Being pregnant or preparing for pregnancy
- Life expectancy \< 12 month
- Without informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.