Glasgow Natural History Study Of Covered Coronary Interventions (GNOCCI)

October 18, 2022 updated by: Dr Thomas J Ford, NHS National Waiting Times Centre Board
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing invasive coronary angiography with planned myocardial revascularisation using percutaneous coronary intervention.

Description

Inclusion Criteria:

  • Any coronary artery perforation during percutaneous coronary intervention

Exclusion Criteria:

  • Nil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary artery perforation (iatrogenic)
Any coronary artery perforation defined according to the Ellis criteria.
Device: Covered coronary stent
Insertion of covered coronary stent as part of standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural major adverse cardiac events (pMACE)
Time Frame: 24 hours of the index procedure.
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
Time Frame: Up to 10 years
death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery
Up to 10 years
Stent thrombosis
Time Frame: Up to 10 years
ARC definite or probable
Up to 10 years
Unsuccessful covered stent deployment
Time Frame: 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
24 hours of the index procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS National Waiting Times Centre Board

Investigators

  • Principal Investigator: Tom J Ford, MBChB (Hons), GJNH/University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Contact PI for data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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