Skip to main content
OpenTrials
Completed

NCT Number: NCT06720935

Use of Coils During Percutaneous Coronary Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Percutaneous Coronary Intervention (PCI) Aneurysm Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Aneurysm Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

San Luigi Gonzaga Hospital

Orbassano, Turin, 10098, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Rate of Technical Success

    Time frame: intraprocedural

    Rate of technical success is defined as effective sealing of coronary perforation or coronary fistulas/aneurysm after coils embolization

Secondary outcomes

  1. Rate of Procedural success

    Time frame: Intraprocedural

    Rate of technical success without In Hospital Major Cardiovascular Events including death, target vessel myocardial infarction and re-PCI or CABG

Sponsors and collaborators

Lead sponsor

San Luigi Gonzaga Hospital

Other

Registry information

Official study title

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

Acronym: COILSEAL

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Dec 6, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.