Serial Changes After Drug-Coated Balloon

Coronary Artery Disease Clinical Trial

— HEAL-aDCB  

Official title:

Morphological Changes of Plaque and Factors Influencing Plaque Healing After Drug-Coated Balloon for de Novo Coronary Lesions: A Optical Coherence Tomography Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636931
• Other study ID #: HEAL-aDCB
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: November 2020
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Da Yin, PhD
• Phone: 86-0411-83635963-2161
• Email: dlyinda[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
China	First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major cardiovascular adverse events rate	In patients treated by DCB, the safety objectives are to evaluate the occurrence of any adverse events in 1 year (re-infarction, re-hospitalization, revascularization by PCI or CABG, cardiac death, stoke, and major bleeding).	1-year follow-up
Secondary	Differences in lesion characteristics evaluated by OCT between baseline and follow-up.	Lesion characteristics evaluated by OCT include lipid-rich plaque, fibrous plaque, macrophage, cholesterol crystal, microchannels and calcification and minimal lumen area (MLA). The follow-up OCT assessment will be performed 12 months after the treatment procedure.	1-year follow-up
Secondary	Differences in lipid-plaque characteristics evaluated by OCT between baseline and follow-up in setting of lipid-plaque.	The characteristics of lipid-plaque evaluated by OCT include lipid core length, mean lipid arc, max lipid arc, fibrous cap thickness (FCT). The follow-up OCT assessment will be performed 12 months after the treatment procedure.	1-year follow-up
Secondary	The incidence of late lumen loss (LLL) at follow-up.	LLL is defined as MLA at follow-up - MLA at baseline < 0.	1-year follow-up
Secondary	Differences in OCT-defined characteristics at baseline according to the presence of late lumen loss (LLL) at follow-up.	All the patients are divided into two groups according to presence of late lumen loss (LLL) at follow-up. The OCT-defined characteristics include plaque rupture, plaque erosion, lipid-rich plaque, fibrous plaque, macrophage, cholesterol crystal, microchannels and calcification. If the plaque is rich in lipid, the lipid core length, mean lipid arc, max lipid arc, fibrous cap thickness (FCT) will be compared.	1-year follow-up