STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)

ConditionsCoronary Artery Disease Atherosclerotic Plaque De Novo Stenosis

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

This trial does not accept healthy volunteers

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 population

Patients with significant multi-vessel coronary artery disease requiring revascularization

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

SeQuent Please Neo
Device
DCB angioplasty will be performed in accordance with the recent recommendations. Specifically, aggressive lesion predilation (balloon-to-artery ratio: 0.8 to 1.2) using either a plain balloon or a scoring balloon will be performed.

Treatment groups

65 Participants

are divided into 1 treatment group

Group A: Patients with multivessel CAD undergoing DCB PCI1 intervention

Trial outcomes

Primary outcomes

Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion

ΔLCBI: NIRS-assessed changes in LCBI between baseline and follow-up.

Time frame

6~9 month

Secondary outcomes

Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion.

ΔPlaque burden: IVUS-assessed changes in plaque burden between baseline and follow-up.

Time frame

6~9 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korea University Ansan Hospital

Lead sponsor

B. Braun Korea Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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