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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension, Renovascular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

intervention group: treated with drug eluting balloon control group :treated with plain old balloon

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The patients are randomly allocated into intervention and control group. The investigator and outcomes assessor only kwow the random number. The participants will not be told the exact group that they were allocated.

Study Groups

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DEB group

angioplasty with paclitaxel eluting balloon

Group Type EXPERIMENTAL

Angioplasty with paclitaxel eluting balloon

Intervention Type DEVICE

The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon

POB group

Angioplasty with plain old balloon

Group Type PLACEBO_COMPARATOR

Angioplasty with plain old balloon

Intervention Type DEVICE

Angioplasty with plain old balloon

Interventions

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Angioplasty with paclitaxel eluting balloon

The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon

Intervention Type DEVICE

Angioplasty with plain old balloon

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No