Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in South Korea / NCT05438121
Recruiting Observational

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

NCT05438121 · tracked via the Priya Life Science South Korea tracker
Sponsor
Korea University Ansan Hospital
Phase
Observational
Started
2022-10-13
Last updated
2024-10-15

Condition(s) studied

Coronary Artery DiseaseAtherosclerotic PlaqueDe Novo Stenosis

Investigational drug(s) / intervention(s)

SeQuent Please Neo

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 outcome measure(s)

  • Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion — 6~9 month
    ΔLCBI: NIRS-assessed changes in LCBI between baseline and follow-up.

Trial sites (1)

FacilityCityRegionStatus
Korea University Ansan Hospital Ansan-si Gyeonggi-do Recruiting

Other trials for the same condition

Prospective Pecutaneous Coronary Intervention Registry Recruiting
AI-Powered Electrocardiography for Diagnosis and Prognostic Prediction in Cardiovascular Disease (AI-CVD): Multicenter Retrospective Study Recruiting
Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice Recruiting
The DECISION-CTO Extended 10 Y Follow-up Recruiting
PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2 Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05438121 on ClinicalTrials.gov ↗ ← All trials in South Korea