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

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

Recruiting
60 years and older
All
Phase N/A

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Overview

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

Inclusion Criteria:

  • 1. older than 60 years of age.
  • 2. meeting the indications for coronary intervention.
  • 3. 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);
  • 4. Target lesion vessel diameter > 2.5 mm

Exclusion Criteria:

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

Study details
    Coronary Artery Disease

NCT05750771

Henan Institute of Cardiovascular Epidemiology

25 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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