Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-11-30
2018-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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drug eluting balloon group
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 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.
drug eluting stent group
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.
drug eluting stent
with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.
Interventions
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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.
drug eluting stent
with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Single-vessel or double-vessel disease
* Length of target lesion \< 25mm
* Diameter of target vessel \>2.5mm, \< 3.5mm
Exclusion Criteria
* Chronic total occlusion
* Severe Tortuosity
* Heavy calcification
* Severe liver failure, moderate or severe kidney failure
* Malignant disease
* Active infectious disease
* Pregnancy or breastfeeding
18 Years
85 Years
ALL
No
Sponsors
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Yun Dai Chen
OTHER
Responsible Party
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Yun Dai Chen
MD
Principal Investigators
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CHEN YUN DAI, MD
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of PLA
Locations
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The General Hospital of PLA
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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LI BO, MD
Role: primary
References
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Li B, Ding Y, Tian F, Chen W, Han T, Chen Y. Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial. Cardiology. 2017;136(4):252-257. doi: 10.1159/000452125. Epub 2016 Nov 16.
Other Identifiers
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301_xnk1
Identifier Type: -
Identifier Source: org_study_id