Coronary Artery PerforationGNOCCINCT03862352
Glasgow Natural History Study Of Covered Coronary Interventions
An observational study of Coronary Artery Perforation and Coronary Stent Occlusion, run by NHS National Waiting Times Centre Board at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Perforation, Coronary Stent Occlusion, Stent Thrombosis
- What is being tested?
- Covered coronary stent
- Type of treatment
- Medical device
- How many people
- 161 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2000to 1 Jan 2022
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients undergoing invasive coronary angiography with planned myocardial revascularisation using percutaneous coronary intervention.
Who may be able to join
- Any coronary artery perforation during percutaneous coronary intervention
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Evaluate procedural and long term outcomes after coronary perforation
- Long term safety and clinical events in patients treated with covered stents.
- Being tested
- Covered coronary stent
- Keywords
- Coronary artery perforation, Covered coronary stent, Calcific coronary disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covered coronary stentDevice
Insertion of covered coronary stent as part of standard care
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery perforation (iatrogenic) | Any coronary artery perforation defined according to the Ellis criteria. Receives: Device: Covered coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural major adverse cardiac events (pMACE)
Defined as a composite of death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery
Measured: 24 hours of the index procedure.
Secondary outcomes (3)
MACE
death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery
Measured: Up to 10 years
Stent thrombosis
ARC definite or probable
Measured: 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
Measured: 24 hours of the index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jan 2000
- Primary completion1 Jan 2020
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 161 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- NHS National Waiting Times Centre Board
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Thomas J Ford, NHS National Waiting Times Centre Board
- Investigators
- Tom J Ford, MBChB (Hons), Principal investigator, GJNH/University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862352
- Sponsor's protocol ID
- 1.0
- Acronym
- GNOCCI
- Status last verified
- Oct 2022
- First submitted
- 28 Feb 2019
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact PI for data sharing
Publications
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.
PubMed 36129052
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glasgow Natural History Study Of Covered Coronary Interventions
- ClinicalTrials.gov ID
- NCT03862352
- Acronym / sponsor ID
- GNOCCI / 1.0
- Keywords
- Coronary artery perforation, Covered coronary stent, Calcific coronary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- NHS National Waiting Times Centre BoardUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate procedural and long term outcomes after coronary perforation
- Long term safety and clinical events in patients treated with covered stents.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary artery perforation (iatrogenic) | – | Device: Covered coronary stentAny coronary artery perforation defined according to the Ellis criteria. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients undergoing invasive coronary angiography with planned myocardial revascularisation using percutaneous coronary intervention.
Key inclusion criteria (1 listed)
- Any coronary artery perforation during percutaneous coronary intervention
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covered coronary stentInsertion of covered coronary stent as part of standard care | Device | Coronary artery perforation (iatrogenic) |
Primary outcome
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
3 secondary outcomes
MACE
Time frame: Up to 10 years
Stent thrombosis
Time frame: Up to 10 years
Unsuccessful covered stent deployment
Time frame: 24 hours of the index procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Derived from this study: PubMed 36129052Ford 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.
- Individual participant dataSharing planned: Yes. Contact PI for data sharing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom J Ford, MBChB (Hons) principal investigator
GJNH/University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Perforation and Coronary Stent Occlusion, run by NHS National Waiting Times Centre Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural major adverse cardiac events (pMACE) (time frame: 24 hours of the index procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03862352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.