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

Henan Institute of Cardiovascular Epidemiology2 sites in 1 country218 target enrollmentFebruary 20, 2023

ConditionsCoronary Artery Disease

InterventionsDES DCB

Overview

Phase: Not Applicable
Intervention: DES
Conditions: Coronary Artery Disease
Sponsor: Henan Institute of Cardiovascular Epidemiology
Enrollment: 218
Locations: 2
Primary Endpoint: LLL
Status: Completed
Last Updated: 26 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 20, 2023

End Date

August 1, 2025

Last Updated

26 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Henan Institute of Cardiovascular Epidemiology

Responsible Party

Sponsor

Eligibility Criteria

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) ;
•4\. Target lesion vessel diameter \> 2.75 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