An observational study in Coronary Artery Disease, sponsored by The First Affiliated Hospital of Dalian Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by The First Affiliated Hospital of Dalian Medical University · Observational
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 200 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →The First Affiliated Hospital of Dalian Medical University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
CAD patients
Exclusion Criteria:
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).
Time frame: 1-year follow-up
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.
Time frame: 1-year follow-up
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.
Time frame: 1-year follow-up
The incidence of late lumen loss (LLL) at follow-up.
LLL is defined as MLA at follow-up - MLA at baseline \< 0.
Time frame: 1-year follow-up
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.
Time frame: 1-year follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital of Dalian Medical University