Coronary Artery Perforation, Coronary Stent Occlusion, Stent Thrombosis
Conditions
Keywords
Coronary artery perforation, Covered coronary stent, Calcific coronary disease
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.
Interventions
DEVICECovered coronary stent
Insertion of covered coronary stent as part of standard care
Sponsors
NHS National Waiting Times Centre Board
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any coronary artery perforation during percutaneous coronary intervention
Exclusion criteria
* Nil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| MACE | Up to 10 years | death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery |
| Stent thrombosis | Up to 10 years | ARC definite or probable |
| 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 |
Countries
United Kingdom
Outcome results
None listed