Angiolite Registry Study

NCT ID: NCT07004569

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2025-07-28

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.

Conditions

With Left Main Coronary Artery Lesions

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients using AngioliteTM Stent with Left Main Coronary Artery Lesions

This is an investigator-initiated, prospective, single-centre, non-randomized registry that evaluates the safety and efficacy of the AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent (iVascular, Barcelona, Spain) for the treatment of LMCA disease.

Percutaneous coronary intervention (PCI)

Intervention Type: DEVICE

Patients is under Percutaneous coronary intervention (PCI) by using contemporary drug eluting stent (DES). Angiolite is a thin-strut cobalt-chromium durable fluoroacrylate polymer-based, sirolimus-eluting stent that is CE marked and commercially available. Stent sizes 2.0mm to 4.5mm in 9mm to 49mm lengths will be used.

Interventions

Percutaneous coronary intervention (PCI)

Patients is under Percutaneous coronary intervention (PCI) by using contemporary drug eluting stent (DES). Angiolite is a thin-strut cobalt-chromium durable fluoroacrylate polymer-based, sirolimus-eluting stent that is CE marked and commercially available. Stent sizes 2.0mm to 4.5mm in 9mm to 49mm lengths will be used.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

GuangMing Tan

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Facility Contacts

Daniel Xu

Role: primary

danielxu@cuhk.edu.hk

35051518 ext. 1518

Other Identifiers

2024.682

Identifier Type: -

Identifier Source: org_study_id