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

RECRUITINGN/ASponsored by Henan Institute of Cardiovascular Epidemiology
Actively Recruiting
PhaseN/A
SponsorHenan Institute of Cardiovascular Epidemiology
Started2023-02-20
Est. completion2025-05-20
Eligibility
Age60 Years+
Healthy vol.Accepted

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

Age: 60 Years+Healthy volunteers accepted
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

Conditions2

Coronary Artery DiseaseHeart Disease

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