Covered Stents in Treatment of Coronary Artery Perforation

NCT ID: NCT04630314

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2020-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Perforation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Percutaneous coronary intervention Coronary artery perforation Covered stent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Consecutive patients treated with covered stents post PCI CAP

Percutaneus Coronary Intervention

Intervention Type DEVICE

Covered Stent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Percutaneus Coronary Intervention

Covered Stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wojciech Wańha

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Invasive Cardiology, Medical University of Białystok

Bialystok, , Poland

Site Status

First Department of Cardiology, Medical University of Gdansk

Gdansk, , Poland

Site Status

Wojciech Wańha

Katowice, , Poland

Site Status

Second Department of Cardiology, Jagiellonian University Medical College

Krakow, , Poland

Site Status

Miedziowe Centrum Zdrowia S.A.

Lubin, , Poland

Site Status

Third Department of Cardiology, Medical University of Katowice

Zabrze, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04

Identifier Type: -

Identifier Source: org_study_id