Glasgow Natural History Study Of Covered Coronary Interventions
GNOCCI
1 other identifier
observational
161
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2000
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedOctober 19, 2022
October 1, 2022
20 years
February 28, 2019
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
MACE
Up to 10 years
Stent thrombosis
Up to 10 years
Unsuccessful covered stent deployment
24 hours of the index procedure.
Study Arms (1)
Coronary artery perforation (iatrogenic)
Any coronary artery perforation defined according to the Ellis criteria.
Interventions
Insertion of covered coronary stent as part of standard care
Eligibility Criteria
Adult patients undergoing invasive coronary angiography with planned myocardial revascularisation using percutaneous coronary intervention.
You may qualify if:
- Any coronary artery perforation during percutaneous coronary intervention
You may not qualify if:
- Nil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Golden Jubilee National Hospital
Glasgow, United Kingdom
Related Publications (1)
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.
PMID: 36129052DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Tom J Ford, MBChB (Hons)
GJNH/University of Glasgow
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Fellow | Honorary Fellow (Interventional Cardiology)
Study Record Dates
First Submitted
February 28, 2019
First Posted
March 5, 2019
Study Start
January 1, 2000
Primary Completion
January 1, 2020
Study Completion
January 1, 2022
Last Updated
October 19, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
Contact PI for data sharing