NCT06262971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

4.6 years

First QC Date

February 8, 2024

Last Update Submit

February 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR)

    1 year

  • Procedure-Related Complications Within 30 Days of PCI

    1 month

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

    1 year

  • Rate of stent thrombosis

    1 month, 3 months, 1 year

Interventions

balloon angioplasty, stent implantation, atherectomy, intravascular ultrasound.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr Ozgur Ulas Ozcan

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

June 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations