Clinical trial NCT07004569: Angiolite Registry Study
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: With Left Main Coronary Artery Lesions
Keywords: Polymer-based Sirolimus-Eluting Stent
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include up to 50 patients of both genders who meet the eligibility criteria listed below and agree to participate in the trial

Brief summary: 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.

Detailed description: 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.

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.

Primary outcomes:
measure: change in Device oriented clinical endpoint (DOCE)
timeFrame: baseline, 1 month, 6 months, 12 months, 24 months
Secondary outcomes:
Other outcomes:
measure: Lesion successful rate
timeFrame: baseline, 1 month, 6 months, 12 months, 24 months
measure: Device successful rate
timeFrame: baseline, 1 month, 6 months, 12 months, 24 months
measure: Procedural successful rate
timeFrame: baseline, 1 month, 6 months, 12 months, 24 months
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
References: