Use of Coils During Percutaneous Coronary Intervention

NCT06720935 | Completed

• 1 other identifier: 002-2024
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention (PCI); Coronary Artery Disease

Keywords

Coils; Coronary Artery Perforation; Coronary Fistulas; Coronary aneurysm

Outcome Measures

Primary Outcomes (1)

• Rate of Technical Success

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

  intraprocedural

Secondary Outcomes (1)

• Rate of Procedural success

  Intraprocedural

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery perforation or coronary fistula/aneurysm treated with coils embolization during percutaneous coronary intervention

You may qualify if:

• Patients with coronary artery perforation or coronary artery fistula/aneurysm suitable treating with coils embolization

You may not qualify if:

• Patients without coronary artery disease suitable of coils treatment

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (1)

San Luigi Gonzaga Hospital

Orbassano, Turin, 10098, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Aneurysm

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aneurysm

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 28, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

IT (1)