Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital

Completed

• Conditions: Coronary Artery Disease; Left Main Coronary Artery Disease

• Registration Number: NCT06262971
• Lead Sponsor: Medipol University

Brief Summary

This hospital-based registry study at Istanbul Medipol University Hospital focuses on documenting and analyzing the clinical and demographic characteristics, procedural-related aspects, and both short and long-term outcomes of patients undergoing left main coronary artery percutaneous coronary intervention (PCI). The study aims to identify predictors for adverse clinical outcomes in patients treated for left main coronary artery disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3620

Inclusion Criteria

• All patients undergoing any PCI procedure(s) in given timeframe will be included in this registry

Exclusion Criteria

• Patients with no informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI	up to 1 month, 3 months, 1 year	The primary outcome measure will be the incidence of major adverse cardiac events (MACE) within one year post-procedure in patients undergoing left main coronary artery PCI. MACE is defined as a composite of clinically significant endpoints including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, and any revascularization procedures required after the initial PCI.

Secondary Outcome Measures

Name	Time	Method
Procedure-Related Complications Within 30 Days of PCI	1 month	This outcome will document the incidence of procedure-related complications, including bleeding, vascular complications, or acute kidney injury, occurring within 30 days post-PCI.
Rate of stent thrombosis	1 month, 3 months, 1 year	Probable or definite stent thrombosis
Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR)	1 year	Revascularization procedure that is performed on a previously treated vessel in patients who have developed ischemia.
Health-Related Quality of Life (HRQoL) Scores One Year After PCI	1 year	Health-related quality of life using standardized questionnaire (SF-36) one year after the PCI procedure

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Turkey