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Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137614
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Jiang lindi, 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.


Condition or disease Intervention/treatment Phase
Takayasu Arteritis Procedure: Drug coated balloon (DCB) Procedure: Digital substraction angiography (DSA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 30, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arm Intervention/treatment
Placebo Comparator: Digital substraction angiography Procedure: Digital substraction angiography (DSA)
DSA was used to evaluated the stenosis of renal artery

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




Primary Outcome Measures :
  1. the control of blood pressure after DCB [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. the re-stenosis rate after DCB [ Time Frame: 6 month ]
  2. the control of blood pressure after DCB [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137614


Locations
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China, Shanghai
Lindi Jiang Recruiting
Shanghai, Shanghai, China, 200032
Contact: Lindi Jiang, Ph.D    86-02164041990    zsh-rheum@hotmail.com   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Publications of Results:

Other Publications:
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Responsible Party: Jiang lindi, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04137614    
Other Study ID Numbers: TADCB2019
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Artery Obstruction
Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases