NCT02760732

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

2.6 years

First QC Date

February 29, 2016

Last Update Submit

November 28, 2017

Conditions

Angina, Unstable

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence rate of MACE

    Incidence rate of MACE from baseline to 12 months

Study Arms (2)

drug eluting balloon group

EXPERIMENTAL

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

drug eluting stent group

EXPERIMENTAL

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

Interventions

drug eluting balloon; cutting balloonDEVICE

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.

Also known as: Sequent please; B. Braun; Flextome Cutting Balloon, Boston Scientific
drug eluting balloon group
drug eluting stentDEVICE

with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.

Also known as: YINYI®
drug eluting stent group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The General Hospital of PLA

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27846629DERIVED

MeSH Terms

Conditions

Angina, Unstable

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • CHEN YUN DAI, MD

    The General Hospital of PLA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LI BO, MD

CONTACT

+860105549930922401919@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 29, 2016

First Posted

May 4, 2016

Study Start

November 1, 2015

Primary Completion

June 1, 2018

Study Completion

August 1, 2018

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations

CN(1)