Clinical trial NCT04137614: Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Takayasu Arteritis
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: the control of blood pressure after DCB
timeFrame: 6 month
Secondary outcomes:
measure: the re-stenosis rate after DCB
timeFrame: 6 month
measure: the control of blood pressure after DCB
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Lindi Jiang
state: Shanghai
Study officials:
References:
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