MedTrace Logo

Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

NCT04137614 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-06-28

No results posted yet for this study

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.

Conditions

  • Takayasu Arteritis

Interventions

PROCEDURE

Drug coated balloon (DCB)

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

PROCEDURE

Digital substraction angiography (DSA)

DSA was used to evaluated the stenosis of renal artery

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137614 on ClinicalTrials.gov