Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

Takayasu Arteritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137614
• Other study ID #: TADCB2019
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: June 2022
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Renal Artery Obstruction
• Takayasu Arteritis

Intervention

Procedure:
• Drug coated balloon (DCB)
Drug coated balloon (DCB)is a new type of PTA, which could improve the re-stenosis rate significantly.
• Digital substraction angiography (DSA)
DSA was used to evaluated the stenosis of renal artery

Locations

Country	Name	City	State
China	Lindi Jiang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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 F — View 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. Review. — View Citation

Schroë 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 fro — View 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 Cardiova — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the control of blood pressure after DCB		6 month
Secondary	the re-stenosis rate after DCB		6 month
Secondary	the control of blood pressure after DCB		12 months