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Drug Eluting Balloon for Treatment of Unstable Angina

Primary Purpose

Angina, Unstable

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
drug eluting balloon; cutting balloon
drug eluting stent
Sponsored by
Yun Dai Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina, Unstable

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The General Hospital of PLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

drug eluting balloon group

drug eluting stent group

Arm 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) .

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence rate of MACE
MACE include composite of death, myocardial infarction, or target-vessel revascularization

Full Information

First Posted
February 29, 2016
Last Updated
November 28, 2017
Sponsor
Yun Dai Chen
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1. Study Identification

Unique Protocol Identification Number
NCT02760732
Brief Title
Drug Eluting Balloon for Treatment of Unstable Angina
Official Title
Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yun Dai Chen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina, Unstable

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
drug eluting balloon group
Arm Type
Experimental
Arm 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) .
Arm Title
drug eluting stent group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
drug eluting balloon; cutting balloon
Other Intervention Name(s)
Sequent please; B. Braun; Flextome Cutting Balloon, Boston Scientific
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
drug eluting stent
Other Intervention Name(s)
YINYI®
Intervention Description
with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.
Primary Outcome Measure Information:
Title
Changes in Target Lumen assessed by optical coherence tomography
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence rate of MACE
Description
MACE include composite of death, myocardial infarction, or target-vessel revascularization
Time Frame
Incidence rate of MACE from baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LI BO, MD
Phone
+8601055499309
Email
22401919@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHEN YUN DAI, MD
Organizational Affiliation
The General Hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The General Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LI BO, MD
Phone
+8601055499309
Email
22401919@QQ.COM

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27846629
Citation
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.
Results Reference
derived

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Drug Eluting Balloon for Treatment of Unstable Angina

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