STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorKorea University Ansan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Hemodynamically unstable or cardiogenic shock
Left main stenotic lesion or graft vessel lesion
Visible angiographic thrombus, not resolved by balloon angioplasty
Pregnancy or breastfeeding
Trial design
Treatments tested in this trial
- SeQuent Please Neo
Treatment groups
65 Participants
are divided into 1 treatment groupSponsors and collaborators
Korea University Ansan Hospital
Lead sponsor
B. Braun Korea Co., Ltd.
Collaborator
Source ClinicalTrials.gov