Procedural Complications and Long-Term Mortality in Complex Coronary Interventions

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Status: Not yet enrolling

Conditions: Complex Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07202754

2025.04-35

Details and patient eligibility

About

The relative risks for different non-fatal intraprocedural complications during complex percutaneous coronary intervention (PCI) on subsequent mortality have not been described. This study aimed to assess the association between non-fatal intraprocedural complications and late mortality after complex coronary PCI.

Full description

Complex coronary lesions include chronic total occlusion, osteal epicardial lesions, long (diffuse) coronary disease, severe calcific lesions, true bifurcation disease, left main coronary lesion, lesions with severe thrombus, and in-stent restenosis. Non-fatal intraprocedural complications included abrupt occlusion, worsening of thrombolysis in myocardial infarction (TIMI) flow grade (TIMI < 3), major dissection (greater than type B), occurrence of thrombus formation, perforation of the main vessel or side branch, malignant arrhythmias, stroke/transient ischemic attack, and non-coronary major bleeding.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with complex coronary disease
• Aged 18-85 years

Exclusion criteria

• Patients diagnosed with cardiogenic shock
• Coronary lesions with non-complex features
• Percutaneous coronary intervention with a bare metal stent
• Patient life expectancy <1 year
• Known relevant allergies
• Absence of all medical records
• Patients with early discontinuation of dual antiplatelet therapy

Trial design

20,000 participants in 2 patient groups

Group 1

Description:

Non-fatal complications (+)

Group 2

Description:

Non-fatal complications (-)