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Completed

NCT Number: NCT03862352

Glasgow Natural History Study Of Covered Coronary Interventions

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.

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Key information

Conditions

Coronary Artery Perforation Coronary Stent Occlusion Stent Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Golden Jubilee National Hospital

Glasgow, United Kingdom

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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any coronary artery perforation during percutaneous coronary intervention

Exclusion criteria

  • Nil

Treatment and study plan

Covered coronary stent

Device

Insertion of covered coronary stent as part of standard care

Primary outcomes

  1. 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

Secondary outcomes

  1. MACE

    Time frame: Up to 10 years

    death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery

  2. Stent thrombosis

    Time frame: Up to 10 years

    ARC definite or probable

  3. 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

Sponsors and collaborators

Lead sponsor

NHS National Waiting Times Centre Board

Other

Registry information

Acronym: GNOCCI

Important dates

Study start
2000
Primary completion
2020
Study completion
2022
First posted
Mar 5, 2019
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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