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ClinicalTrials.gov ID

NCT03080519

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

5,000Estimated

Last Update Posted

Mar 15, 2017Actual

Start Date

Apr 2017Estimated

Primary Completion Date

Apr 2022Estimated

Completion Date

Apr 2024Estimated

Official Title

A Multicenter Registry of Endovascular Therapy for Renal Artery Stenosis in China

Brief Summary

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.

Detailed Description

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.

• Renal Artery Obstruction
• Hypertension, Renovascular

• Endovascular Therapy

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

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