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NCT06262971 Clinical Trial

Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital

Coronary Artery Disease Clinical Trial

Official title:
Comprehensive Registry of Left Main Coronary Artery Percutaneous Coronary Intervention Outcomes at Istanbul Medipol University Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06262971
Other study ID # PCI-LM-Registry-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2023

Study information
Verified date February 2024
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 3620
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Percutaneous coronary intervention
balloon angioplasty, stent implantation, atherectomy, intravascular ultrasound.

Locations
Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI 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. up to 1 month, 3 months, 1 year
Secondary Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR) Revascularization procedure that is performed on a previously treated vessel in patients who have developed ischemia. 1 year
Secondary Procedure-Related Complications Within 30 Days of PCI This outcome will document the incidence of procedure-related complications, including bleeding, vascular complications, or acute kidney injury, occurring within 30 days post-PCI. 1 month
Secondary Health-Related Quality of Life (HRQoL) Scores One Year After PCI Health-related quality of life using standardized questionnaire (SF-36) one year after the PCI procedure 1 year
Secondary Rate of stent thrombosis Probable or definite stent thrombosis 1 month, 3 months, 1 year
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