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

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.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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