Angiolite Registry Study

Launched by CHINESE UNIVERSITY OF HONG KONG · May 27, 2025

Keywords

ClinConnect Summary

The Angiolite Registry Study is researching a specific type of heart treatment for patients who have problems with their left main coronary artery, which supplies blood to a large part of the heart. This study will look at how well a new type of stent, called the Angiolite stent, works for patients needing a procedure known as percutaneous coronary intervention (PCI) to treat significant blockages in this artery. Unlike other studies that excluded these patients, this trial aims to gather important information about the safety and effectiveness of the Angiolite stent in real-world settings.

To be eligible for this study, participants need to be over 18 years old and require PCI for blockages in their left main coronary artery, with a blockage of more than 50% but less than 100%. They should also be able to give informed consent, meaning they understand the study and agree to participate. Participants can expect close monitoring during the procedure and for up to 24 months afterward to track their health and any results from the stent. It’s important to note that certain individuals, like those with allergies to specific materials used in the stent, pregnant or breastfeeding women, or those involved in other conflicting studies, will not be able to join this trial.

Gender

ALL

Eligibility 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.