Clinical trial NCT04366596: Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis
Official title: Comparison of Drug-eluting Balloon and Plain Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension, Renovascular
Keywords: Renal Artery Obstruction
Takayasu Arteritis
Fibromuscular Dysplasia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group: treated with drug eluting balloon control group :treated with plain old balloon
Primary purpose: TREATMENT

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 group will be treated with plain old balloon(POB). The primary endpoint is efficacy of blood pressure control.

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. Endovascular intervention is micro-invasive but with high restenosis rate. Drug eluting balloon(DEB) has been demonstrated to be effective for preventing restenosis in peripheral arteries. This study aims to test the efficacy of drug eluting balloon for non-atherosclerotic renal artery stenosis. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon. The primary endpoint is efficacy of blood pressure control.

Eligibility criteria: Inclusion Criteria:

1. age between 18y and 45y.
2. with ≥ 60% stenosis in at least one renal artery.
3. with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
4. patients with no severe renal insufficiency (eGFR\>30 ml/min, length of the kidney ≥ 7cm).
5. Good compliance.
6. with informed consent.

Exclusion Criteria:

1. With apparent atherosclerotic risk factors.
2. With renal intervention or surgery history.
3. With congenital anatomical anomaly.
4. With severe renal insufficiency (length of the target kidney \< 7cm, total eGFR\<30ml/min, divided eGFR of the target kidney\<8 ml/min)
5. With contraindication for antiplatelet therapy.
6. With severe cardiopulmonary insufficiency.
7. Allergic to contrast medium
8. Being pregnant or preparing for pregnancy
9. With active cancer.
10. Life expectancy \< 12 month
11. Without informed consent.

Primary outcomes:
measure: Clinical benefit rate(cure or improvement of hypertension)
timeFrame: 9 months
measure: Primary patency rate
timeFrame: 9 months
Secondary outcomes:
measure: Technical success rate
timeFrame: immediately after intervention
measure: complication rate
timeFrame: within 30 days post-intervention
measure: Bail-out stenting rate
timeFrame: during the procedure
measure: Clinical benefit rate
timeFrame: 1, 3,6,12 months
measure: primary patency rate
timeFrame: 6,12 months
measure: Renal function
timeFrame: 6,9,12 months
measure: Renal function
timeFrame: 6,9,12 months
measure: secondary patency rate
timeFrame: 9, 12 months
measure: Target lesion revascularization
timeFrame: 9,12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuehong Zheng, MD
role: STUDY_CHAIR
References: