Endovascular Therapy for Renal Artery Stenosis in China

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

NA

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2024-04-30

Brief Summary

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A multicenter prospective registry planned to recruit more than 5 000 patients with renal artery stenosis was carried out in China. This primary purpose of this study was to evaluate the safety and efficacy of renal artery revascularization in the real world. The secondary purpose was to investigate the etiologic distribution of renal artery stenosis and optimize the indications for renal artery revascularization.

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Detailed Description

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Currently,the endovascular therapy of renal artery stenosis (especially atherosclerotic) remains in dispute. Some randomized control trials published in recent years (including ASTRAL and CORAL trials) showed the lack of additional benefit for renal artery revascularization compared with sole medical therapy. However,these randomized control trials presented a number of limitations including low numbers of patients and non-stringent inclusion criteria. Given clinical medical practice entering the era of big data, the large-sample real-word studies would be more objective to answer some pending issues of randomized controlled trial.Therefore,a multicenter prospective registry planned to recruit more than 5 000 patients with renal artery stenosis was carried out. This primary purpose of this study was to evaluate the safety and efficacy of renal artery revascularization in the real world. The secondary purpose was to investigate the etiologic distribution of renal artery stenosis and optimize the indications for renal artery revascularization.

Conditions

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Renal Artery Obstruction Hypertension, Renovascular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intervational Therapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endovascular Therapy

Renal artery revascularization

Group Type EXPERIMENTAL

Endovascular Therapy

Intervention Type PROCEDURE

Balloon angioplasty and stenting for renal artery stenosis

Interventions

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Endovascular Therapy

Balloon angioplasty and stenting for renal artery stenosis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 14 at the time of informed consent
2. Diameter reduction of renal artery or main branch of renal artery≥ 60%,and ≥2 of four following conditions met:1)systolic hyperemic pressure gradient \>20 mm Hg,2)captopril renoscitigraphy positive in the lesion side

,3)renin-angiotensin-aldosterone system significantly activated and 4)severe reduction (\>25%) of glomendar filtration rate in the lesion side
3. office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg while receiving 3 antihypertensive drugs,or office systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg without antihypertensive drugs
4. Serum creatinine level\<264umol/L
5. Length of ipsilateral kidney ≥7.0 cm and glomendar filtration rate ≥10 ml／min
6. Urine protein \<2+

Exclusion Criteria

1. Unable to provide informed consent
2. Unstable condition and unable to tolerate interventional therapy
3. intolerance to antiplatelet drugs or contrast medium
4. vascular anatomy not suitable for endovascular therapy
5. Pregnant, nursing, or planning to be pregnant

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No