Drug Eluting Balloon for Treatment of Unstable Angina

November 28, 2017 updated by: Yun Dai Chen

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • The General Hospital of PLA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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) .
Device: 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.
Other Names:
  • Sequent please; B. Braun; Flextome Cutting Balloon, Boston Scientific
Experimental: 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.
Device: drug eluting stent
with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.
Other Names:
  • YINYI®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yun Dai Chen

Investigators

  • Principal Investigator: CHEN YUN DAI, MD, The General Hospital of PLA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

April 30, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301_xnk1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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