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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Hypertension, Renovascular

Treatments: Device: Angioplasty with plain old balloon; Device: Angioplasty with paclitaxel eluting balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT04366596

HS-2133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

DEB group

Experimental group

Description:

angioplasty with paclitaxel eluting balloon

Treatment:

Device: Angioplasty with paclitaxel eluting balloon

POB group

Placebo Comparator group

Description:

Angioplasty with plain old balloon

Treatment:

Device: Angioplasty with plain old balloon