RecruitingNot ApplicableNCT05750771

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

Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease

Sponsor

Henan Institute of Cardiovascular Epidemiology

Enrollment

200 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease

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

Min Age: 60 Years

Inclusion Criteria4

\. older than 60 years of age.
\. meeting the indications for coronary intervention.
\. 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);
\. Target lesion vessel diameter > 2.5 mm

Exclusion Criteria7

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