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Use of Coils During Percutaneous Coronary Intervention

NCT ID: NCT06720935

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-09-28

Brief Summary

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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

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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

Conditions

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Percutaneous Coronary Intervention (PCI) Coronary Artery Disease

Keywords

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Coils Coronary Artery Perforation Coronary Fistulas Coronary aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients undergoing to percutaneous coronary intervention with coils

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Luigi Gonzaga Hospital

OTHER

Sponsor Role lead

Responsible Party

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Enrico Cerrato

Interventional Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Luigi Gonzaga Hospital

Orbassano, Turin, Italy

Site Status

Countries

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Italy

Other Identifiers

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002-2024

Identifier Type: -

Identifier Source: org_study_id