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Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

Primary Purpose

Takayasu Arteritis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug coated balloon (DCB)
Digital substraction angiography (DSA)
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Takayasu Arteritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lindi JiangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Digital substraction angiography

Drug-coated balloon

Arm Description

Outcomes

Primary Outcome Measures

the control of blood pressure after DCB

Secondary Outcome Measures

the re-stenosis rate after DCB
the control of blood pressure after DCB

Full Information

First Posted
October 22, 2019
Last Updated
June 25, 2022
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04137614
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takayasu Arteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital substraction angiography
Arm Type
Placebo Comparator
Arm Title
Drug-coated balloon
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Drug coated balloon (DCB)
Intervention Description
Drug coated balloon (DCB)is a new type of PTA, which could improve the re-stenosis rate significantly.
Intervention Type
Procedure
Intervention Name(s)
Digital substraction angiography (DSA)
Intervention Description
DSA was used to evaluated the stenosis of renal artery
Primary Outcome Measure Information:
Title
the control of blood pressure after DCB
Time Frame
6 month
Secondary Outcome Measure Information:
Title
the re-stenosis rate after DCB
Time Frame
6 month
Title
the control of blood pressure after DCB
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-60 years old; diagnosed as Takayasu arteritis according to 1990 ACR classification renal artery stenosis is confirmed by imaging results had inactive disease, and the dose of glucocorticoids <10mg/day blood pressure >160/90mmHg in spite of two or more antihypertensive drug had no surgery of renal artery, including PTA, stent, or others. Exclusion Criteria: blood pressure >200/120mmHg in spite of two or more antihypertensive drug had severe disease conditions allergy to contrast agent had other autoimmune disease had severe abnormal lab test result
Facility Information:
Facility Name
Lindi Jiang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindi Jiang, Ph.D
Phone
86-02164041990
Email
zsh-rheum@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17328078
Citation
Maksimowicz-McKinnon K, Clark TM, Hoffman GS. Limitations of therapy and a guarded prognosis in an American cohort of Takayasu arteritis patients. Arthritis Rheum. 2007 Mar;56(3):1000-9. doi: 10.1002/art.22404.
Results Reference
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PubMed Identifier
30698358
Citation
Misra DP, Wakhlu A, Agarwal V, Danda D. Recent advances in the management of Takayasu arteritis. Int J Rheum Dis. 2019 Jan;22 Suppl 1:60-68. doi: 10.1111/1756-185X.13285.
Results Reference
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PubMed Identifier
7923672
Citation
Ishikawa K, Maetani S. Long-term outcome for 120 Japanese patients with Takayasu's disease. Clinical and statistical analyses of related prognostic factors. Circulation. 1994 Oct;90(4):1855-60. doi: 10.1161/01.cir.90.4.1855.
Results Reference
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PubMed Identifier
28629556
Citation
van den Berg JC. Drug-eluting balloons for treatment of SFA and popliteal disease - A review of current status. Eur J Radiol. 2017 Jun;91:106-115. doi: 10.1016/j.ejrad.2017.03.015. Epub 2017 Mar 27.
Results Reference
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PubMed Identifier
29086462
Citation
Schroe H, Holden AH, Goueffic Y, Jansen SJ, Peeters P, Keirse K, Ito W, Vermassen F, Micari A, Blessing E, Jaff MR, Zeller T. Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study. Catheter Cardiovasc Interv. 2018 Feb 15;91(3):497-504. doi: 10.1002/ccd.27348. Epub 2017 Oct 31.
Results Reference
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PubMed Identifier
28780030
Citation
Thieme M, Von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M; Lutonix Global SFA Registry Investigators. The 24-Month Results of the Lutonix Global SFA Registry: Worldwide Experience With Lutonix Drug-Coated Balloon. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1682-1690. doi: 10.1016/j.jcin.2017.04.041. Epub 2017 Aug 2.
Results Reference
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PubMed Identifier
29798770
Citation
Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.
Results Reference
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PubMed Identifier
24675165
Citation
Zhu G, He F, Gu Y, Yu H, Chen B, Hu Z, Liang W, Wang Z. Angioplasty for pediatric renovascular hypertension: a 13-year experience. Diagn Interv Radiol. 2014 May-Jun;20(3):285-92. doi: 10.5152/dir.2014.13208.
Results Reference
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PubMed Identifier
26304483
Citation
Kim YW, Sung K, Park YJ, Kim DK. Surgical treatment of middle aortic syndrome due to Takayasu arteritis. J Vasc Surg. 2015 Sep;62(3):750-1. doi: 10.1016/j.jvs.2014.05.017. No abstract available.
Results Reference
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PubMed Identifier
26712071
Citation
Kinjo H, Kafa A. The results of treatment in renal artery stenosis due to Takayasu disease: comparison between surgery, angioplasty, and stenting. A monocentrique retrospective study. G Chir. 2015 Jul-Aug;36(4):161-7. doi: 10.11138/gchir/2015.36.4.161.
Results Reference
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Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

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