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OpenTrials
Completed

NCT Number: NCT04630314

Covered Stents in Treatment of Coronary Artery Perforation

Covered stents have been mainly used for treatment of potentially life-threatening coronary artery perforation and coronary artery aneurysm. Prior studies suggest that the use of covered stents improves event-free survival, enabling a life-threatening situation to be managed without emergency surgery and with significantly reduced rates of mortality, cardiac tamponade, and major adverse cardiac events. Although the devices are used for a long time, very limited study has described procedural-related outcomes with this specific technology. We therefore want to report procedural, in-hospital and long term outcomes among patients treated with the covered stents.

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Key information

Study type

Observational

Primary location

Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland

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Who can participate

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

Inclusion criteria

  • Iatrogenic, peri-PCI CAP treated with covered stent implantation

Exclusion criteria

  • CAP caused due to other cause than PCI
  • PCI of other vascular territories during the same procedure

Treatment and study plan

Percutaneus Coronary Intervention

Device

Covered Stent

Primary outcomes

  1. Major Adverse Cardiac Events (MACE)

    Time frame: 1 year

    MACE

Secondary outcomes

  1. Stent Thrombosis (ST)

    Time frame: 1 year

    ST

  2. Cardiac Death

    Time frame: 1 year

    CV Death

  3. Target Lesion Revascularization (TLR)

    Time frame: 1 year

    TLR

  4. Myocardial Infarction (MI)

    Time frame: 1 year

    MI

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Procedural and 1-year Outcomes Following Large Vessel Coronary Artery Perforation Treated by Covered Stents Implantation: Multicentre CRACK Registry

Acronym: CRACK

Important dates

Study start
2009
Primary completion
2019
Study completion
2020
First posted
Nov 16, 2020
Registry last updated
Nov 16, 2020

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

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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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