NCT04630314

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

10.8 years

First QC Date

November 13, 2020

Last Update Submit

November 13, 2020

Conditions

Coronary Artery Perforation

Keywords

Percutaneous coronary interventionCoronary artery perforationCovered stent

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events (MACE)

    MACE

    1 year

Secondary Outcomes (4)

  • Stent Thrombosis (ST)

    1 year

  • Cardiac Death

    1 year

  • Target Lesion Revascularization (TLR)

    1 year

  • Myocardial Infarction (MI)

    1 year

Study Arms (1)

Consecutive patients treated with covered stents post PCI CAP

Device: Percutaneus Coronary Intervention

Interventions

Percutaneus Coronary InterventionDEVICE

Covered Stent

Consecutive patients treated with covered stents post PCI CAP

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All consecutive patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Invasive Cardiology, Medical University of Białystok

Bialystok, Poland

Location

First Department of Cardiology, Medical University of Gdansk

Gdansk, Poland

Location

Wojciech Wańha

Katowice, 40-055, Poland

Location

Second Department of Cardiology, Jagiellonian University Medical College

Krakow, Poland

Location

Miedziowe Centrum Zdrowia S.A.

Lubin, Poland

Location

Third Department of Cardiology, Medical University of Katowice

Zabrze, Poland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 16, 2020

Study Start

January 1, 2009

Primary Completion

November 1, 2019

Study Completion

November 1, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations

PL(6)