Drug Eluting Balloon for Treatment of Unstable Angina

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

Detailed Description
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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) .

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

Conditions
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Angina, Unstable

Intervention / Treatment
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* Device: drug eluting balloon; cutting balloon
* Device: drug eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drug eluting balloon group<br>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) . | Device: drug eluting balloon; cutting balloon<br>* 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.<br>* Other names: Sequent please; B. Braun; Flextome Cutting Balloon, Boston Scientific;|
| Experimental: drug eluting stent group<br>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. | Device: drug eluting stent<br>* with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.<br>* Other names: YINYI®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Target Lumen assessed by optical coherence tomography | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of MACE | MACE include composite of death, myocardial infarction, or target-vessel revascularization | Incidence rate of MACE from baseline to 12 months |