Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04137614

Enrollment

Registered

2019-10-24

Start date

2019-11-30

Completion date

2022-11-30

Last updated

2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takayasu Arteritis

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.

Interventions

PROCEDUREDigital substraction angiography (DSA)

DSA was used to evaluated the stenosis of renal artery

PROCEDUREDrug coated balloon (DCB)

Drug coated balloon (DCB）is a new type of PTA, which could improve the re-stenosis rate significantly.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
the control of blood pressure after DCB	6 month

Secondary

Measure	Time frame
the re-stenosis rate after DCB	6 month
the control of blood pressure after DCB	12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026