Angiolite stent registry for left main coronary artery lesions
Official title: A Prospective, Non-Randomized, Clinical Registry of The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent in The Treatment of Patients With Left Main Coronary Artery Lesions
Run by Chinese University of Hong Kong · NCT07004569 · Data updated 2026-11-12
This registry will test whether the Angiolite sirolimus‑eluting stent is safe and works well for adults having PCI to treat left main coronary artery narrowing.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Shatin) |
| Status | Recruiting |
| Started | May 28, 2024 |
| Main results expected | May 30, 2025 |
| Study ends | July 28, 2025 |
| Registry record updated | June 4, 2025 |
| Trial ID | NCT07004569 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with angiographic left main stenosis (50–<100%) and a target vessel diameter of 2.0–6.0 mm who are scheduled for PCI and can give informed consent are ideal candidates.
✕Probably not a fit
Patients with a known allergy to sirolimus or fluoroacrylate, pregnant or breastfeeding women, or those whose lesions cannot accommodate the study stent are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry enrolls adults undergoing percutaneous coronary intervention (PCI) for left main coronary artery lesions who receive the Angiolite thin‑strut cobalt‑chromium sirolimus‑eluting stent. Investigators will collect procedural details, device performance including overexpansion behavior at bifurcations, and clinical outcomes such as procedural success, myocardial infarction, and target lesion failure during follow‑up. The protocol includes patients with stable coronary disease and acute coronary syndromes if their anatomy is suitable and lesions have 50–<100% stenosis and a reference vessel diameter of 2.0–6.0 mm. Data will be gathered at a single lead site in Hong Kong to characterize real‑world use and safety of the stent in left main disease.
Why it matters
Potential benefit: If successful, using the Angiolite stent could reduce complications related to overexpansion and improve durability and outcomes after PCI in left main lesions.
How similar studies have gone: A prior randomized ANGIOLITE trial showed non‑inferiority of the Angiolite stent versus conventional DES, but patients with left main disease were largely excluded, so LMCA‑specific evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject age \>18. 2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent. 3. Indication for a percutaneous coronary intervention (PCI) in native epicardial arteries involving left main coronary artery, including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction and ST-elevation myocardial infarction). 4. Target lesion must have a stenosis of \>50% and \<100% angiographically. 5. Target lesion much have an angiographic reference vessel diameter of 2.0-6.0 mm. 6. All lesions requiring PCI should be amendable for implantation of study stents. Exclusion Criteria: 1. Known history of an allergic reaction or significant sensitivity to sirolimus or other analogue or derivative. 2. Known history of an allergic reaction or significant sensitivity to fluoroacrylate or its analogue or derivative. 3. Pregnant or breastfeeding woman. 4. Currently participating in another device study that has not completed the primary end point or that clinically interferes with the current study endpoints.
Where it's running
-
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.