Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis

Phase 3

• Conditions: Hypertension, Renovascular
• Interventions: Device: Angioplasty with plain old balloon; Device: Angioplasty with paclitaxel eluting balloon

• Registration Number: NCT04366596
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-10-01
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-29
• Last Update Posted: 2020-04-29
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POB group	Angioplasty with plain old balloon	Angioplasty with plain old balloon
DEB group	Angioplasty with paclitaxel eluting balloon	angioplasty with paclitaxel eluting balloon

Primary Outcome Measures

Name	Time	Method
Clinical benefit rate(cure or improvement of hypertension)	9 months	Cure: diastolic blood pressure \<90 mm Hg and systolic blood pressure \<140 mm Hg off antihypertensive medications. Improvement: diastolic blood pressure \<90 mm Hg and/or systolic blood pressure \<140 mm Hg on the same or reduced number of medications (or reduced number of defined daily doses as described by the World Health Organization ) or a reduction in diastolic blood pressure by at least 15 mm Hg on the same or reduced number of medications
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
Technical success rate	immediately after intervention	No residual stenosis more than 50%
complication rate	within 30 days post-intervention	All complications occurring within 30 days or during the same hospitalization as the revascularization procedure
primary patency rate	6,12 months
secondary patency rate	9, 12 months	any procedure that restores patency after occlusion
Target lesion revascularization	9,12 months	either repeat percutaneous or surgical revascularization for a lesion anywhere within the angioplasty region or the 5-mm borders proximal or distal to angioplasty region
Clinical benefit rate	1, 3,6,12 months
Bail-out stenting rate	during the procedure	Stent implanted after angioplasty for residual stenosis of dissection
Renal function	6,9,12 months	serum Cr

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China