Drug Eluting Balloon for Treatment of Unstable Angina

Not Applicable

• Conditions: Angina, Unstable
• Interventions: Device: drug eluting balloon; cutting balloon; Device: drug eluting stent

• Registration Number: NCT02760732
• Lead Sponsor: Yun Dai Chen

Brief 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) .

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-04-30
• Study First Posted: 2016-05-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-30
• Primary Completion: 2018-06-01
• Study Completion: 2018-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug eluting balloon group	drug eluting balloon; cutting balloon	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) .
drug eluting stent group	drug eluting stent	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.

Primary Outcome Measures

Name	Time	Method
Changes in Target Lumen assessed by optical coherence tomography	12 months	A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months.

Secondary Outcome Measures

Name	Time	Method
Incidence rate of MACE	Incidence rate of MACE from baseline to 12 months	MACE include composite of death, myocardial infarction, or target-vessel revascularization

Trial Locations

Locations (1)

The General Hospital of PLA; 🇨🇳 Beijing, Beijing, China