Actively Recruiting
Angiolite Registry Study
Led by Chinese University of Hong Kong · Updated on 2025-06-04
55
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Percutaneous coronary intervention (PCI) using contemporary drug eluting stent (DES) is one of the treatment options for patients with significant LMCA disease and suitable anatomy as multiple randomized controlled trials and meta-analysis have demonstrated the feasibility and safety of PCI in the treatment of LMCA disease. There are a few challenges in LMCA PCI due to certain anatomical and structural factors. The LMCA disease frequently involves bifurcations which requires special considerations such as side-branch access and preservation in order to prevent procedural related myocardial infarction (MI). Implantation of a metallic scaffold across the LMCA bifurcation often requires aggressive post-dilatation of the LMCA stent due to the diameter discrepancy between the side-branch and the LMCA main body. However, overexpansion beyond the rated diameter might compromise the stent integrity and radial force, resulting in mal-apposition, vascular recoil and risk of subsequent target lesion failure (TLF). The Angiolite stent is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design and a high overexpansion capacity that might overcomes some of these challenges in LMCA PCI. The ANGIOLITE randomized trial confirmed the non-inferiority of the Angiolite stent against the conventional DES. However, patients with LMCA involvement were specifically excluded from the trial. We therefore propose to investigate the procedural and 24 months clinical performance of the Angiolite stent in the treatment of patients with LMCA lesions.
CONDITIONS
Official Title
Angiolite Registry Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Patient or legal guardian understands the trial and provides written informed consent
- Requires PCI in native epicardial arteries involving the left main coronary artery, including stable coronary artery disease and acute coronary syndromes
- Target lesion has more than 50% and less than 100% narrowing on angiography
- Target lesion vessel diameter between 2.0 and 6.0 mm
- Lesions suitable for implantation of study stents
You will not qualify if you...
- Known allergy or significant sensitivity to sirolimus or similar drugs
- Known allergy or significant sensitivity to fluoroacrylate or similar substances
- Pregnant or breastfeeding women
- Currently enrolled in another device study that has not completed primary endpoints or interferes with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong, 0000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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