Clinical trial NCT05438121: STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Atherosclerotic Plaque
De Novo Stenosis
Keywords: drug coated balloon
Near infrared spectroscopy
NIRS-IVUS
De novo coronary lesion
Lead sponsor: Korea University Ansan Hospital
Sponsor class: OTHER
Collaborators: name: B. Braun Korea Co., Ltd.
First posted: 2022-06-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with significant multi-vessel coronary artery disease requiring revascularization

Brief summary: 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.

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

Primary outcomes:
measure: Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion
timeFrame: 6~9 month
Secondary outcomes:
measure: Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion.
timeFrame: 6~9 month
Other outcomes:
Locations:
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Korea University Ansan Hospital
name: Sunwon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.