Drug Eluting Balloon in The Treatment of Unstable Angina

Clinical Trials.gov
10 Jun, 2019 ,

Yun Dai Chen et.al. are conducting a Randomised Interventional trial in 60 participants in order to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina. Patients with unstable angina will be randomized to drug eluting stent only or drug eluting balloon group. 

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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


Ages Eligible for Study:  18 Years to 85 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No


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