Use of Coils During Percutaneous Coronary Intervention

Completed

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

• Registration Number: NCT06720935
• Lead Sponsor: San Luigi Gonzaga Hospital

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

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-28
• Study First Submitted: 2024-09-29
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

San Luigi Gonzaga Hospital; 🇮🇹 Orbassano, Turin, Italy