Use of Coils During Percutaneous Coronary Intervention

Contemporary Use of Coils During Percutaneous Coronary Intervention: From the Multicenter COILSEAL Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06720935

Acronym

COILSEAL

Enrollment

143

Registered

2024-12-06

Start date

2024-01-01

Completion date

2024-09-28

Last updated

2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)

Keywords

Coils, Coronary Artery Perforation, Coronary Fistulas, Coronary aneurysm

Brief summary

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.

Detailed 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of Technical Success	intraprocedural	Rate of technical success is defined as effective sealing of coronary perforation or coronary fistulas/aneurysm after coils embolization

Secondary

Measure	Time frame	Description
Rate of Procedural success	Intraprocedural	Rate of technical success without In Hospital Major Cardiovascular Events including death, target vessel myocardial infarction and re-PCI or CABG

Countries

Italy

Outcome results