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Takayasu ArteritisNCT04137614

Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

A study testing Drug coated balloon (DCB) and Digital substraction angiography (DSA) in people with Takayasu Arteritis, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Takayasu Arteritis
What is being tested?
Drug coated balloon (DCB) and Digital substraction angiography (DSA)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
30 Nov 2019to 30 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Lindi Jiang

    Shanghai, Shanghai Municipality, 200032

    Lindi Jiang, Ph.D, 86-02164041990, zsh-rheum@hotmail.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Drug coated balloon (DCB), Digital substraction angiography (DSA)
Medical subject headings
Takayasu Arteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug coated balloon (DCB)Procedure or surgery

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

  • Digital substraction angiography (DSA)Procedure or surgery

    DSA was used to evaluated the stenosis of renal artery

Study groups in NCT04137614
Study groupRoleWhat they receive
Digital substraction angiographyPlacebo comparatorNot described
Receives: Procedure: Digital substraction angiography (DSA)
Drug-coated balloonExperimentalNot described
Receives: Procedure: Drug coated balloon (DCB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the control of blood pressure after DCB

    Measured: 6 month

Secondary outcomes (2)

  1. the re-stenosis rate after DCB

    Measured: 6 month

  2. the control of blood pressure after DCB

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2019
  2. Study start30 Nov 2019
  3. Primary completion30 Nov 2022 (estimated)
  4. Study completion30 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04137614
Sponsor's protocol ID
TADCB2019
Status last verified
Jun 2022
First submitted
22 Oct 2019
Last updated
28 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 17328078

  • 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.

    PubMed 30698358

  • 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.

    PubMed 7923672

  • 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.

    PubMed 28629556

  • 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.

    PubMed 29086462

  • 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.

    PubMed 28780030

  • 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.

    PubMed 29798770

  • 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.

    PubMed 24675165

  • 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.

    PubMed 26304483

  • 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.

    PubMed 26712071

Questions about this trial

What is this clinical trial studying?

A study testing Drug coated balloon (DCB) and Digital substraction angiography (DSA) in people with Takayasu Arteritis, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the control of blood pressure after DCB (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04137614, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.

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