ClinicalTrials.Veeva

Menu

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

H

Henan Institute of Cardiovascular Epidemiology

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Device: DCB
Device: DES

Study type

Interventional

Funder types

Other

Identifiers

NCT05750771
HenanICE202303

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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 criteria

    1. inability to provide written informed consent.
    1. unable to administer antiplatelet agents and anticoagulant therapy; have allergies 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

DCB Group
Experimental group
Description:
Implantation of drug-coated balloons in patients with satisfactory pretreatment
Treatment:
Device: DCB
DES Group
Experimental group
Description:
Implantation of drug-eluting stents in patients with satisfactory pretreatment
Treatment:
Device: DES

Trial contacts and locations

1

Loading...

Central trial contact

Quan Guo, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems