Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

Study Overview
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Brief Summary
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Takayasu arteritis associated renal artery stenosis (TARAS) is the biggest cause of hypertension in young people <40 years old. Hypertension caused by renal artery stenosis is usually hard to control in spite of two or more anti-hypertension drugs. Percutaneous transluminal angioplasty (PTA) is recommended for hypertension caused by TARAS. In previous clinical practice, we observed relatively effects of PTA on controlling the blood pressure in patients with TARAS. But, high re-stenosis rate was also indicated. Drug coated balloon (DCB）is a new type of PTA, which could improve the re-stenosis rate significantly. In the clinical trials of peripheral vascular disease, it has been confirmed that DCB had lower re-stenosis rate than PTA. However, up to date, no studies was found about the use of DBC in TARAS. Thus, this study was design as a random, double blind trial to evaluated the effects and safety of DCB in the treatment of hypertension caused by TARAS.

Official Title
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The Effects and Safety of Drug-coated Balloon in the Treatment of Hypertension Caused by Takayasu Arteritis Associated Renal Artery Stenosis: a Single Centre, Random, Double Blind Trial

Conditions
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Takayasu Arteritis

Intervention / Treatment
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* Procedure: Drug coated balloon (DCB)
* Procedure: Digital substraction angiography (DSA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years old; diagnosed as Takayasu arteritis according to 1990 ACR classification renal artery stenosis is confirmed by imaging results had inactive disease, and the dose of glucocorticoids <10mg/day blood pressure >160/90mmHg in spite of two or more antihypertensive drug had no surgery of renal artery, including PTA, stent, or others. Exclusion Criteria: blood pressure >200/120mmHg in spite of two or more antihypertensive drug had severe disease conditions allergy to contrast agent had other autoimmune disease had severe abnormal lab test result

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Digital substraction angiography<br> | Procedure: Digital substraction angiography (DSA)<br>* DSA was used to evaluated the stenosis of renal artery<br>|
| Experimental: Drug-coated balloon<br> | Procedure: Drug coated balloon (DCB)<br>* Drug coated balloon (DCB）is a new type of PTA, which could improve the re-stenosis rate significantly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the control of blood pressure after DCB |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the re-stenosis rate after DCB |  | 6 month | 
| the control of blood pressure after DCB |  | 12 months |