Glasgow Natural History Study Of Covered Coronary Interventions

Study Overview
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Brief Summary
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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
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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: Evaluate procedural and long term outcomes after coronary perforation Long term safety and clinical events in patients treated with covered stents.

Official Title
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Glasgow Natural History Study Of Covered Coronary Interventions

Conditions
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Coronary Artery Perforation, Coronary Stent Occlusion, Stent Thrombosis

Intervention / Treatment
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* Device: Covered coronary stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any coronary artery perforation during percutaneous coronary intervention Exclusion Criteria: Nil
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary artery perforation (iatrogenic)<br>Any coronary artery perforation defined according to the Ellis criteria. | Device: Covered coronary stent<br>* Insertion of covered coronary stent as part of standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural major adverse cardiac events (pMACE) | Defined as a composite of death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery | 24 hours of the index procedure. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery perforation, Covered coronary stent, Calcific coronary disease