Covered Stents in Treatment of Coronary Artery Perforation

Coronary Artery Perforation Clinical Trial

— CRACK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630314
• Other study ID #: 04
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Perforation

Intervention

Device:
• Percutaneus Coronary Intervention
Covered Stent

Locations

Country	Name	City	State
Poland	Department of Invasive Cardiology, Medical University of Bialystok	Bialystok
Poland	First Department of Cardiology, Medical University of Gdansk	Gdansk
Poland	Wojciech Wanha	Katowice
Poland	Second Department of Cardiology, Jagiellonian University Medical College	Kraków
Poland	Miedziowe Centrum Zdrowia S.A.	Lubin
Poland	Third Department of Cardiology, Medical University of Katowice	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE)	MACE	1 year
Secondary	Stent Thrombosis (ST)	ST	1 year
Secondary	Cardiac Death	CV Death	1 year
Secondary	Target Lesion Revascularization (TLR)	TLR	1 year
Secondary	Myocardial Infarction (MI)	MI	1 year