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NCT04137614
Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis
NA trial testing Drug coated balloon (DCB) in Takayasu Arteritis in 30 participants. Status unknown.
30 November 2022
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 30 November 2019 |
| Primary completion | 30 November 2022 |
| Estimated completion | 30 November 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Drug coated balloon (DCB)
- Digital substraction angiography (DSA)
Conditions studied
- Takayasu Arteritis — all drugs for Takayasu Arteritis →
Sponsor
Shanghai Zhongshan Hospital
Who can join
Adults 18 to 60, any sex, with Takayasu Arteritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT04137614
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04137614 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 28 June 2022
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