Covered Stents in Treatment of Coronary Artery Perforation

Completed

• Conditions: Coronary Artery Perforation
• Interventions: Device: Percutaneus Coronary Intervention

• Registration Number: NCT04630314
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2019-11-01
• Status Verified: 2020-11
• Study Completion: 2020-11-01
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Last Update Submitted: 2020-11-13
• Study First Posted: 2020-11-16
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 119

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consecutive patients treated with covered stents post PCI CAP	Percutaneus Coronary Intervention	-

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	1 year	MACE

Secondary Outcome Measures

Name	Time	Method
Myocardial Infarction (MI)	1 year	MI
Stent Thrombosis (ST)	1 year	ST
Cardiac Death	1 year	CV Death
Target Lesion Revascularization (TLR)	1 year	TLR

Trial Locations

Locations (6)

First Department of Cardiology, Medical University of Gdansk; 🇵🇱 Gdańsk, Poland

Third Department of Cardiology, Medical University of Katowice; 🇵🇱 Zabrze, Poland

Wojciech Wańha; 🇵🇱 Katowice, Poland

Second Department of Cardiology, Jagiellonian University Medical College; 🇵🇱 Kraków, Poland

Miedziowe Centrum Zdrowia S.A.; 🇵🇱 Lubin, Poland

Department of Invasive Cardiology, Medical University of Białystok; 🇵🇱 Białystok, Poland