Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

Not Applicable

• Conditions: Takayasu Arteritis
• Interventions: Procedure: Drug coated balloon (DCB); Procedure: Digital substraction angiography (DSA)

• Registration Number: NCT04137614
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2019-11-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-25
• Last Update Posted: 2022-06-28
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug-coated balloon	Drug coated balloon (DCB)	-
Digital substraction angiography	Digital substraction angiography (DSA)	-

Primary Outcome Measures

Name	Time	Method
the control of blood pressure after DCB	6 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lindi Jiang; 🇨🇳 Shanghai, Shanghai, China