NCT02760732

Drug Eluting Balloon for Treatment of Unstable Angina

Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yun Dai Chen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.

Detailed description

Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .

Conditions

• Angina, Unstable

Interventions

Type	Name	Description
DEVICE	drug eluting balloon; cutting balloon	Patients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon.
DEVICE	drug eluting stent	with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-06-01
• Completion: 2018-08-01
• First posted: 2016-05-04
• Last updated: 2017-11-30

Locations

1 site across 1 country: China