Status:
UNKNOWN
Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Hypertension, Renovascular
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
Brief Summary
Efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis will be tested in this study. The intervention group will be treated with paclitaxel eluting balloon. The control gr...
Detailed Description
Renal artery stenosis is common cause for hypertension in young people. It could be treated with open surgery or endovascular intervention. Open surgery has relatively high complication rate. Endovasc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04366596
Start Date
October 1 2019
End Date
October 1 2023
Last Update
April 29 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100037