An observational study in Percutaneous Coronary Intervention (PCI) and Coronary Artery Disease, sponsored by San Luigi Gonzaga Hospital. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by San Luigi Gonzaga Hospital · Observational
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.
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
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 143 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →San Luigi Gonzaga Hospital is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
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Patients with coronary artery perforation or coronary fistula/aneurysm treated with coils embolization during percutaneous coronary intervention
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Exclusion Criteria:
The study involves patients undergoing coils embolization for treating coronary artery perforation or coronary fistulas/aneurysm during percutaneous coronary intervention
Rate of Technical Success
Rate of technical success is defined as effective sealing of coronary perforation or coronary fistulas/aneurysm after coils embolization
Time frame: intraprocedural
Rate of Procedural success
Rate of technical success without In Hospital Major Cardiovascular Events including death, target vessel myocardial infarction and re-PCI or CABG
Time frame: Intraprocedural
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Sep 2024, 8 months.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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San Luigi Gonzaga Hospital