Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-05 @ 6:16 PM
Study NCT ID:
NCT07004569
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angiolite Registry Study
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: