Drug Eluting Balloon for Treatment of Unstable Angina

Yun Dai Chen

Status: Unknown

Conditions: Angina, Unstable

Treatments: Device: drug eluting balloon; cutting balloon; Device: drug eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02760732

301_xnk1

Details and patient eligibility

About

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

Full 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) .

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients > 18, < 80 years old, with unstable angina
• Single-vessel or double-vessel disease
• Length of target lesion < 25mm
• Diameter of target vessel >2.5mm, < 3.5mm

Exclusion criteria

• Left main disease
• Chronic total occlusion
• Severe Tortuosity
• Heavy calcification
• Severe liver failure, moderate or severe kidney failure
• Malignant disease
• Active infectious disease
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

drug eluting balloon group

Experimental group

Description:

patients with unstable angina were randomised to drug eluting balloon group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon(Flextome Cutting Balloon, Boston Scientific Corporation, US) pre-dilation first and then drug eluting balloon(Sequent please; B. Braun, Melsungen, Germany) .

Treatment:

Device: drug eluting balloon; cutting balloon

drug eluting stent group

Experimental group

Description:

patients with unstable angina were randomised to this group for drug eluting stent (YINYI® Polymer-free Drug-coated (Paclitaxel) Coronary Stent System, Liaoning Biomedical Materials R\&D Center Co., Ltd. China) implantation.

Treatment:

Device: drug eluting stent