Angiolite Registry Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: With Left Main Coronary Artery Lesions
• Intervention / Treatment: Device: Percutaneous coronary intervention (PCI)

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.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin
    • Hong Kong, Shatin, Hong Kong, 0000
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Daniel Xu; Phone Number: 1518 35051518; Email: danielxu@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion successful rate	Lesion successful rate is achieving less than 30% residual stenosis on angiography after the usage of the study device with lesion preparation and post-dilatation.	baseline, 1 month, 6 months, 12 months, 24 months
Device successful rate	Device successful rate is successful implantation of the study device at the target lesions	baseline, 1 month, 6 months, 12 months, 24 months
Procedural successful rate	Procedural successful rate is lesion success and no DOCE during the index hospitalization.	baseline, 1 month, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): July 28, 2025

Study Registration Dates

• First Submitted: May 27, 2025
• First Submitted That Met QC Criteria: May 27, 2025
• First Posted (Actual): June 4, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Polymer-based Sirolimus-Eluting Stent
• Other Study ID Numbers: 2024.682

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No