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Drug Eluting Balloon for Treatment of Unstable Angina

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ClinicalTrials.gov Identifier: NCT02760732
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Yun Dai Chen, Chinese PLA General Hospital

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

Condition or disease Intervention/treatment Phase
Angina, Unstable Device: drug eluting balloon; cutting balloon Device: drug eluting stent Not Applicable

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) .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina
Study Start Date : November 2015
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

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 Name: 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 Name: YINYI®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760732


Contacts
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Contact: LI BO, MD +8601055499309 22401919@qq.com

Locations
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China, Beijing
The General Hospital of PLA Recruiting
Beijing, Beijing, China, 100853
Contact: LI BO, MD    +8601055499309    22401919@QQ.COM   
Sponsors and Collaborators
Yun Dai Chen
Investigators
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Principal Investigator: CHEN YUN DAI, MD The General Hospital of PLA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yun Dai Chen, MD, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02760732     History of Changes
Other Study ID Numbers: 301_xnk1
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms