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
      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.
    



Study Type

Interventional


Primary Outcome

the control of blood pressure after DCB

Secondary Outcome

 the re-stenosis rate after DCB

Condition

Takayasu Arteritis

Intervention

Drug coated balloon (DCB)

Study Arms / Comparison Groups

 Digital substraction angiography
Description:  

Publications

* 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

Procedure

Estimated Enrollment

30

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
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04137614

Organization ID

TADCB2019


Responsible Party

Principal Investigator

Study Sponsor

Shanghai Zhongshan Hospital


Study Sponsor

, , 


Verification Date

May 2021