Time-trend Analysis of Clinical Characteristic and Outcomes in Patients With Unprotected Left Main Coronary Artery Disease Treated With PCI Over a 10-year Period

NCT ID: NCT05548023

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2025-02-07

Brief Summary

Surgical coronary bypass surgery (CABG) has been demonstrated to confer significant survival benefit over medical therapies patients with LMCA in earlier clinical trials1,2,3 and therefore was the revascularization modality of choice for a long time. Recently, several randomized controlled trials and meta-analyses have shown percutaneous coronary intervention (PCI) to be non-inferior to CABG in the treatment of LMCA disease4,5,6,7,8. PCI is now considered to be an appropriate alternative to CABG for LMCA disease in patients with suitable anatomy9,10. Over recent decades, LMCA PCI has been performed in patients with increasing anatomical complexity and higher risk profiles (e.g. elderly, heart failure, renal failure etc). 11,12. In recent years, remarkable advancement in interventional techniques and technologies such as 2nd/3rd generation DES and potent antiplatelet therapy have contributed to the improvement of PCI success rates and reduction in complications and adverse events. Knowledge related to long term temporal variation of clinical and procedural characteristics and outcomes in patients with LMCA disease treated with PCI will therefore be important to inform and define future treatment strategies. This proposal aims to evaluate time-trends and regional differences in clinical characteristics and outcomes of patients with LMCA disease treated with PCI in the Asia-Pacific region

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

unprotected left main coronary artery disease treated with PCI

Group Type: OTHER

The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent

Intervention Type: DEVICE

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

Interventions

The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Lp(a) ≥ 70 mg/dL at the screening visit
• Optimal LDL-cholesterol lowering treatment
• Optimal treatment of other CV risk factors
• Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
• Ischemic stroke: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
• Clinically significant symptomatic peripheral artery disease

Exclusion Criteria

• Uncontrolled hypertension
• Heart failure New York Heart Association (NYHA) class IV
• History of malignancy of any organ system
• History of hemorrhagic stroke or other major bleeding
• Platelet count <140,000 per μL
• Active liver disease or hepatic dysfunction

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Bryan Ping Yen YAN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bryan Yan

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

2023.464

Identifier Type: -

Identifier Source: org_study_id