NCT04366596

Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis

Comparison of Drug-eluting Balloon and Plain Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis: a Randomized Controlled Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis will be tested in this study. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon(POB). The primary endpoint is efficacy of blood pressure control.

Detailed description

Renal artery stenosis is common cause for hypertension in young people. It could be treated with open surgery or endovascular intervention. Open surgery has relatively high complication rate. Endovascular intervention is micro-invasive but with high restenosis rate. Drug eluting balloon(DEB) has been demonstrated to be effective for preventing restenosis in peripheral arteries. This study aims to test the efficacy of drug eluting balloon for non-atherosclerotic renal artery stenosis. The intervention group will be treated with paclitaxel eluting balloon. The control group will be treated with plain old balloon. The primary endpoint is efficacy of blood pressure control.

Conditions

• Hypertension, Renovascular

Interventions

Type	Name	Description
DEVICE	Angioplasty with paclitaxel eluting balloon	The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon
DEVICE	Angioplasty with plain old balloon	Angioplasty with plain old balloon

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2020-04-29
• Last updated: 2020-04-29

Locations

1 site across 1 country: China