Serial Changes After Drug-Coated Balloon (HEAL-aDCB)

The First Affiliated Hospital of Dalian Medical University

Status: Unknown

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04636931

HEAL-aDCB

Details and patient eligibility

About

The study aims at evaluating the morphological changes of plaque estimated by optical coherence tomography (OCT) and Factors Influencing Plaque Healing after Drug-Coated Balloon (DCB) for de Novo Coronary Lesions.

Full description

Percutaneous coronary intervention with a drug-eluting stent (DES) is the most common mode of revascularization for coronary artery disease. However, their efficacy is limited by in-stent restenosis and stent thrombosis. Drug-coated balloon (DCB) deliver an anti-proliferative drug into the vessel wall and leave nothing behind, which is a promising technique in the treatment of coronary artery disease. Previous many studies have confirmed that DCB treatment for de Novo coronary lesions is safe and efficient. But, data about morphological changes of plaque and factors influencing plaque healing after DCB for de Novo Coronary Lesions is scarce. The study compares morphological changes of plaques evaluated by OCT between baseline and 1-year follow-up and evaluates factors influencing plaque healing. All the included patient will receive dual antiplatelet therapy (DAPT) for one month followed by clopidogrel treatment.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed as CAD underwent coronary angiography and OCT Examination.

• Patients with de novo lesion suitable for DCB treatment.
• The reference diameter of targeted artery ≥2.75mm, the length of targeted lesion ≤25mm.
• Agreed to accept DCB treatment and written the informed consent.

Exclusion criteria

• Patients with de novo lesion unsuitable for DCB treatment.
• In-stent restenosis, coronary dissection, coronary spam, thrombus
• left main artery disease
• Age>80 years old
• Cardiogenic shock or stroke admission
• Severe hepatic or renal dysfunction
• Poor quality of OCT image or massive thrombus
• Disagreed to accept DCB treatment.
• Life expectancy < 1year. Angiographic Exclusion Criteria
• After pre-dilation of targeted lesions, the patients with residual stenosis>30%, TIMI flow <III grade and presence of major dissection (C type or higher).