Glasgow Natural History Study Of Covered Coronary Interventions

Completed

• Conditions: Coronary Artery Perforation; Coronary Stent Occlusion; Stent Thrombosis
• Interventions: Device: Covered coronary stent

• Registration Number: NCT03862352
• Lead Sponsor: NHS National Waiting Times Centre Board

Brief Summary

Covered stents (CS) are a potentially lifesaving treatment for grade III coronary perforation but delivery can be challenging, and the long-term durability and safety including risk of acute stent thrombosis are unknown. The GNOCCI study aims to evaluate long term outcomes after coronary perforation including patients treated with covered stents.

Detailed Description

Covered stents (CS) are a potentially lifesaving treatment for grade III coronary perforation but delivery can be challenging, and the long-term durability and safety including risk of acute stent thrombosis are unknown. Using an electronic data base, details of all coronary perforations are identified and anonymised patient and procedural details are recorded.Procedural major adverse cardiac events (pMACE) are defined as a composite of death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery within 24 hours of the index procedure. Two independent cardiologists adjudicate outcomes and differences in opinion are resolved by consensus with a third cardiologist.

The overall GNOCCI study aims are:

1. Evaluate procedural and long term outcomes after coronary perforation

2. Long term safety and clinical events in patients treated with covered stents.

Study Timeline

• Study Start: 2000-01-01
• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Primary Completion: 2020-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• Any coronary artery perforation during percutaneous coronary intervention

Exclusion Criteria

• Nil

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary artery perforation (iatrogenic)	Covered coronary stent	Any coronary artery perforation defined according to the Ellis criteria.

Primary Outcome Measures

Name	Time	Method
Procedural major adverse cardiac events (pMACE)	24 hours of the index procedure.	Defined as a composite of death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery

Secondary Outcome Measures

Name	Time	Method
Stent thrombosis	Up to 10 years	ARC definite or probable
MACE	Up to 10 years	death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery
Unsuccessful covered stent deployment	24 hours of the index procedure.	Attempted covered stent insertion without sealing of perforation, defined by case review of two independent cardiologists from source files

Trial Locations

Locations (1)

Golden Jubilee National Hospital; 🇬🇧 Glasgow, United Kingdom