NCT04137614

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Takayasu Arteritis

Interventions

Type	Name	Description
PROCEDURE	Drug coated balloon (DCB)	Drug coated balloon (DCB）is a new type of PTA, which could improve the re-stenosis rate significantly.
PROCEDURE	Digital substraction angiography (DSA)	DSA was used to evaluated the stenosis of renal artery

Timeline

• Start date: 2019-11-30
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2019-10-24
• Last updated: 2022-06-28

Locations

1 site across 1 country: China