Angiolite Registry Study

NCT07004569 | Recruiting

• 1 other identifier: 2024.682
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

With Left Main Coronary Artery Lesions

Keywords

Polymer-based Sirolimus-Eluting Stent

Outcome Measures

Primary Outcomes (1)

• change in Device oriented clinical endpoint (DOCE)

  Device oriented clinical endpoint (DOCE) defined as a composite of cardiovascular death, myocardial infarction (Q-wave and non-Q wave), emergent coronary artery bypass graft surgery, target vessel myocardial infarction (TV-MI) or repeat clinically driven target-lesion revascularization (TLR) by percutaneous or surgical methods.

  baseline, 1 month, 6 months, 12 months, 24 months

Other Outcomes (3)

• Lesion successful rate

  baseline, 1 month, 6 months, 12 months, 24 months

• Device successful rate

  baseline, 1 month, 6 months, 12 months, 24 months

• Procedural successful rate

  baseline, 1 month, 6 months, 12 months, 24 months

Study Arms (1)

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.

Device: Percutaneous coronary intervention (PCI)

Interventions

Percutaneous coronary intervention (PCI) 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.

Patients using AngioliteTM Stent with Left Main Coronary Artery Lesions

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Subject age \>18.
• Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent.
• 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).
• Target lesion must have a stenosis of \>50% and \<100% angiographically.
• Target lesion much have an angiographic reference vessel diameter of 2.0-6.0 mm.
• All lesions requiring PCI should be amendable for implantation of study stents.

You may not qualify if:

• Known history of an allergic reaction or significant sensitivity to sirolimus or other analogue or derivative.
• Known history of an allergic reaction or significant sensitivity to fluoroacrylate or its analogue or derivative.
• Pregnant or breastfeeding woman.
• Currently participating in another device study that has not completed the primary end point or that clinically interferes with the current study endpoints.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, 0000, Hong Kong

RECRUITING

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: May 28, 2024
• Primary Completion: May 30, 2025
• Study Completion: July 28, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

HK (1)