NCT04137614

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 30, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

3 years

First QC Date

October 22, 2019

Last Update Submit

June 25, 2022

Conditions

Takayasu Arteritis

Outcome Measures

Primary Outcomes (1)

  • the control of blood pressure after DCB

    6 month

Secondary Outcomes (2)

  • the re-stenosis rate after DCB

    6 month

  • the control of blood pressure after DCB

    12 months

Study Arms (2)

Digital substraction angiography

PLACEBO COMPARATOR
Procedure: Digital substraction angiography (DSA)

Drug-coated balloon

EXPERIMENTAL
Procedure: Drug coated balloon (DCB)

Interventions

Drug coated balloon (DCB)PROCEDURE

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

Drug-coated balloon
Digital substraction angiography (DSA)PROCEDURE

DSA was used to evaluated the stenosis of renal artery

Digital substraction angiography

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindi Jiang

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 17328078BACKGROUND

  • 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.

    PMID: 30698358BACKGROUND

  • 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.

    PMID: 7923672BACKGROUND

  • 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.

    PMID: 28629556RESULT

  • 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.

    PMID: 29086462RESULT

  • 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.

    PMID: 28780030RESULT

  • 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.

    PMID: 29798770RESULT

  • 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.

    PMID: 24675165RESULT

  • 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.

    PMID: 26304483RESULT

  • 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.

    PMID: 26712071RESULT

MeSH Terms

Conditions

Takayasu Arteritis

Condition Hierarchy (Ancestors)

Aortic Arch SyndromesAortic DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shanghai Zhongshan Hospital

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 24, 2019

Study Start

November 30, 2019

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06

Locations

CN(1)