Use of Coils During Percutaneous Coronary Intervention (COILSEAL)

San Luigi Gonzaga Hospital

Status: Completed

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention (PCI)

Study type: Observational

Funder types: Other

Identifiers

NCT06720935

002-2024

Details and patient eligibility

About

Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes. The study aims to report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.

Full description

Background. Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes Objectives. To report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.

Methods. Among 245.652 PCIs performed in 17 high-volume European centers, patients treated with coils will be identified.

The primary outcome was technical success, defined as the successful sealing coronary perforation or aneurysm/fistulas and procedural success defined as technical success without in-hospital Major Cardiovascular Events (MACe). Long-term MACE and mortality were also reported

Enrollment: 143 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with coronary artery perforation or coronary artery fistula/aneurysm suitable treating with coils embolization

Exclusion criteria

• Patients without coronary artery disease suitable of coils treatment

Trial design

143 participants in 1 patient group

Patients undergoing to percutaneous coronary intervention with coils

Description:

The study involves patients undergoing coils embolization for treating coronary artery perforation or coronary fistulas/aneurysm during percutaneous coronary intervention