Glasgow Natural History Study Of Covered Coronary Interventions

Stent Thrombosis Clinical Trial

— GNOCCI  

Official title:

Glasgow Natural History Study Of Covered Coronary Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862352
• Other study ID #: 1.0
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2022
• Source: NHS National Waiting Times Centre Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. The GNOCCI study aims to evaluate long term outcomes after coronary perforation including patients treated with covered stents.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any coronary artery perforation during percutaneous coronary intervention

Exclusion Criteria:

• Nil

Related Conditions & MeSH terms

• Coronary Artery Perforation
• Coronary Stent Occlusion
• Stent Thrombosis
• Thrombosis

Intervention

Device:
• Covered coronary stent
Insertion of covered coronary stent as part of standard care

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
NHS National Waiting Times Centre Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MACE	death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery	Up to 10 years
Secondary	Stent thrombosis	ARC definite or probable	Up to 10 years
Secondary	Unsuccessful covered stent deployment	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.