Menu
Recruiting NCT05438121

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

— Observational Coronary Artery Disease Atherosclerotic Plaque De Novo Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SeQuent Please Neo.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Atherosclerotic Plaque, De Novo Stenosis. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study

Overview

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.

Detailed description

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.

Interventions

  • Device 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.

Primary outcome measures

  • Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion [Time frame: 6~9 month]
Secondary outcome measures (1)
  • Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion. [Time frame: 6~9 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Korea University Ansan Hospital — Ansan-si

Publications

  • Kleber FX, Mathey DG, Rittger H, Scheller B; German Drug-eluting Balloon Consensus Group. How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention. 2011 May;7 Suppl K:K125-8. doi: 10.4244/EIJV7SKA21. No abstract available. PMID 22027722
  • Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, Hsu JC, Kiam OT, Qiu C, Qian J, Ahmad WAW, Ali RM. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136-149. doi: 10.5603/CJ.a2019.0093. Epub 2019 Sep 30. PMID 31565793
  • Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046. PMID 32138967

Identifiers

NCT: NCT05438121 · AAG-O-H-2205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗