Covered Stents in Treatment of Coronary Artery Perforation (CRACK)

November 13, 2020 updated by: Wojciech Wańha, Medical University of Silesia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Białystok, Poland
        • Department of Invasive Cardiology, Medical University of Białystok
      • Gdańsk, Poland
        • First Department of Cardiology, Medical University of Gdansk
      • Katowice, Poland, 40-055
        • Wojciech Wańha
      • Kraków, Poland
        • Second Department of Cardiology, Jagiellonian University Medical College
      • Lubin, Poland
        • Miedziowe Centrum Zdrowia s.a.
      • Zabrze, Poland
        • Third Department of Cardiology, Medical University of Katowice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

All consecutive patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Consecutive patients treated with covered stents post PCI CAP
Device: Percutaneus Coronary Intervention
Covered Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (MACE)
Time Frame: 1 year
MACE
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent Thrombosis (ST)
Time Frame: 1 year
ST
1 year
Cardiac Death
Time Frame: 1 year
CV Death
1 year
Target Lesion Revascularization (TLR)
Time Frame: 1 year
TLR
1 year
Myocardial Infarction (MI)
Time Frame: 1 year
MI
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

November 1, 2020

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (ACTUAL)

November 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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