Glasgow Natural History Study Of Covered Coronary Interve... | NCT03862352

Studies
Glasgow Natural History Study Of Covered Coronary Interventions

NCT03862352

Sponsor

NHS National Waiting Times Centre Board

Status

Completed

Last Update Posted

Oct 19, 2022Actual

Enrollment

161Actual

Phase

Not provided

Conditions

Coronary Artery Perforation
Coronary Stent Occlusion
Stent Thrombosis

Interventions

Covered coronary stent

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2000Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jan 1, 2022Actual

First Submitted Date

Feb 28, 2019

First Submission Date that Met QC Criteria

Mar 1, 2019

First Posted Date

Mar 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2022

Last Update Posted Date

Oct 19, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Thomas J Ford, Clinical Research Fellow | Honorary Fellow (Interventional Cardiology), NHS National Waiting Times Centre BoardPrincipal Investigator

Lead Sponsor

NHS National Waiting Times Centre BoardOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Evaluate procedural and long term outcomes after coronary perforation
Long term safety and clinical events in patients treated with covered stents.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coronary artery perforation (iatrogenic)		Any coronary artery perforation defined according to the Ellis criteria.	Device: Covered coronary stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Covered coronary stent	Device	Insertion of covered coronary stent as part of standard care	Coronary artery perforation (iatrogenic)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
MACE	death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery	Up to 10 years
Stent thrombosis	ARC definite or probable

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any coronary artery perforation during percutaneous coronary intervention

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tom J Ford, MBChB (Hons)	GJNH/University of Glasgow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Golden Jubilee National Hospital		Glasgow			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36129052	Derived	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.