Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

Fudan University

Status: Enrolling

Conditions: Takayasu Arteritis

Treatments: Procedure: Digital substraction angiography (DSA); Procedure: Drug coated balloon (DCB)

Study type: Interventional

Funder types: Other

Identifiers

NCT04137614

TADCB2019

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-60 years old;
2. diagnosed as Takayasu arteritis according to 1990 ACR classification
3. renal artery stenosis is confirmed by imaging results
4. had inactive disease, and the dose of glucocorticoids <10mg/day
5. blood pressure >160/90mmHg in spite of two or more antihypertensive drug
6. had no surgery of renal artery, including PTA, stent, or others.

Exclusion criteria

1. blood pressure >200/120mmHg in spite of two or more antihypertensive drug
2. had severe disease conditions
3. allergy to contrast agent
4. had other autoimmune disease
5. had severe abnormal lab test result

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Digital substraction angiography

Placebo Comparator group

Treatment:

Procedure: Digital substraction angiography (DSA)

Drug-coated balloon

Experimental group

Treatment:

Procedure: Drug coated balloon (DCB)