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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-13

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions

NCT06954714

Coronary Artery Disease

RECRUITING NA

Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.

NCT06002932

Coronary Artery Disease Ischemic Heart Disease

RECRUITING NA

Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions

NCT05096442

Coronary Artery Disease

COMPLETED NA

Resting Full-cycle Ratio-guided Step by Step Balloon Dilation

NCT05107024

de Novo Coronary Lesions

UNKNOWN NA

Observational Study for Left Main Disease Treatment

NCT01341327

Coronary Artery Disease

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A large lipid core is the hallmark of coronary plaques at risk of rupture and subsequent atherothrombosis. Although statin-based medical treatment is known to regress and stabilize lipid-rich coronary plaques, it takes time for such beneficial effects to appear. This study aims to investigate whether DCB angioplasty can effectively modify de novo coronary atherosclerotic plaque and lead to reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Atherosclerotic Plaque De Novo Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with multivessel CAD undergoing DCB PCI

I. Patients with significant multi-vessel coronary artery disease will be screened.

II. If the patient is found to have at least one lipid-rich plaque (LRP, LCBI\>250) requiring revascularization (DS\>70%) will undergo multi-vessel IVUS-NIRS imaging.

III. If multi-vessel NIRS screening revealed another LRP (LCBI\>250) with DS\<70%, the patient will be enrolled.

IV. The stenotic LRP lesion (DS\>70%) will be subjected to DCB angioplasty while non-stenotic LRP lesion (DS\<70%) will be left unintervened and treated medically.

V. Comparative lesions:

1. DCB-treated LRP (DS\>70%, maxLCBI\>250)
2. Unintervened, medically-treated LRP (DS\<70%, maxLCBI\>250)

SeQuent Please Neo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SeQuent Please Neo

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No