Clinical trial NCT04636931: Serial Changes After Drug-Coated Balloon
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CAD patients

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Major cardiovascular adverse events rate
timeFrame: 1-year follow-up
Secondary outcomes:
measure: Differences in lesion characteristics evaluated by OCT between baseline and follow-up.
timeFrame: 1-year follow-up
measure: Differences in lipid-plaque characteristics evaluated by OCT between baseline and follow-up in setting of lipid-plaque.
timeFrame: 1-year follow-up
measure: The incidence of late lumen loss (LLL) at follow-up.
timeFrame: 1-year follow-up
measure: Differences in OCT-defined characteristics at baseline according to the presence of late lumen loss (LLL) at follow-up.
timeFrame: 1-year follow-up
Other outcomes:
Locations:
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
References: