Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD

Last updated: June 25, 2024
Sponsor: Henan Institute of Cardiovascular Epidemiology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Thrombosis

Chest Pain

Treatment

DES

DCB

Clinical Study ID

NCT05750771
HenanICE202303
  • Ages > 60
  • All Genders

Study Summary

The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.

And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. older than 60 years of age.
  1. meeting the indications for coronary intervention.
  1. IVUS examination suggests severe calcified lesions (calcification angle > 270°at the target lesion) or OCT examination suggests severe calcified lesions (calcification angle > 180° and/or length > 5 mm and/or thickness > 0.5 mm);
  1. Target lesion vessel diameter > 2.5 mm

Exclusion

Exclusion Criteria:

  1. inability to provide written informed consent.
  1. unable to administer antiplatelet agents and anticoagulant therapy; haveallergies to heparin, contrast agents, etc.
  1. the subject is participating in another uncompleted clinical trial
  1. life expectancy <1 year.
  1. non-in situ vascular lesions.
  1. cardiogenic shock.
  1. Patients with hemodynamic instability

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: DES
Phase:
Study Start date:
February 20, 2023
Estimated Completion Date:
December 20, 2025

Connect with a study center

  • Fuwai central China cardiovascular Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

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