NCT05438121Recruiting
STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)
Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study
Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 65 (estimated)
- First submitted
- 24 Jun 2022
- Start date
- 13 Oct 2022
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Korea University Ansan Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05438121
What you commit to
- Study type: Observational
- Planned participants: 65
- From 13 Oct 2022 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Hemodynamically unstable or cardiogenic shock
- Left main stenotic lesion or graft vessel lesion
- Visible angiographic thrombus, not resolved by balloon angioplasty
- Pregnancy or breastfeeding
- Comorbidities with life expectancy \< 12 months
- Severe coronary calcification or tortuosity, hindering timely DCB delivery
Who the study is looking for
- Patients with significant multivessel coronary artery disease requiring revascularization
- Any De novo lesions (reference vessel diameter of 2.25mm\~4.0mm) suitable for DCB angioplasty
- Lesion suitable for intravascular imagings
- Written informed consent
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.