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Completed

NCT Number: NCT06262971

Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Left Main Coronary Artery Disease Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Device

balloon angioplasty, stent implantation, atherectomy, intravascular ultrasound.

Primary outcomes

  1. Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI

    Time frame: 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 outcomes

  1. Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 1 year

    Revascularization procedure that is performed on a previously treated vessel in patients who have developed ischemia.

  2. Procedure-Related Complications Within 30 Days of PCI

    Time frame: 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.

  3. Health-Related Quality of Life (HRQoL) Scores One Year After PCI

    Time frame: 1 year

    Health-related quality of life using standardized questionnaire (SF-36) one year after the PCI procedure

  4. Rate of stent thrombosis

    Time frame: 1 month, 3 months, 1 year

    Probable or definite stent thrombosis

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Feb 16, 2024
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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