Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

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Brief Title

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

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

      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.

Study Type


Primary Outcome

the control of blood pressure after DCB

Secondary Outcome

 the re-stenosis rate after DCB


Takayasu Arteritis


Drug coated balloon (DCB)

Study Arms / Comparison Groups

 Digital substraction angiography


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 30, 2019

Completion Date

November 30, 2022

Primary Completion Date

November 30, 2022

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




18 Years - 60 Years

Accepts Healthy Volunteers



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Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Shanghai Zhongshan Hospital

Study Sponsor

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Verification Date

June 2022