Clinical trial NCT03862352: Glasgow Natural History Study Of Covered Coronary Interventions
Official title: Glasgow Natural History Study Of Covered Coronary Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Perforation
Coronary Stent Occlusion
Stent Thrombosis
Keywords: Coronary artery perforation
Covered coronary stent
Calcific coronary disease
Lead sponsor: NHS National Waiting Times Centre Board
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing invasive coronary angiography with planned myocardial revascularisation using percutaneous coronary intervention.

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.

Eligibility criteria: Inclusion Criteria:

* Any coronary artery perforation during percutaneous coronary intervention

Exclusion Criteria:

* Nil

Primary outcomes:
measure: Procedural major adverse cardiac events (pMACE)
timeFrame: 24 hours of the index procedure.
Secondary outcomes:
measure: MACE
timeFrame: Up to 10 years
measure: Stent thrombosis
timeFrame: Up to 10 years
measure: Unsuccessful covered stent deployment
timeFrame: 24 hours of the index procedure.
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
Study officials:
affiliation: GJNH/University of Glasgow
name: Tom J Ford, MBChB (Hons)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ford TJ, Adamson C, Morrow AJ, Rocchiccioli P, Collison D, McCartney PJ, Shaukat A, Lindsay M, Good R, Watkins S, Eteiba H, Robertson K, Berry C, Oldroyd KG, McEntegart M. Coronary Artery Perforations: Glasgow Natural History Study of Covered Stent Coronary Interventions (GNOCCI) Study. J Am Heart Assoc. 2022 Oct 4;11(19):e024492. doi: 10.1161/JAHA.121.024492. Epub 2022 Sep 21.