PApyrus® STentgraft for Sealing of Coronary PERForations

Recruiting

• Conditions: I25.1; Atherosclerotic heart disease

• Registration Number: DRKS00016956
• Lead Sponsor: Studienzentrum der Herzklinik Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All patients implanted with the Papyrus® second-generation covered stent graft system due to peri-procedural coronary artery perforation.

Exclusion Criteria

None

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary effectiveness endpoint:<br>rate of successful closures of coronary perforation<br>Primary safety endpoint:<br>Combination of all-cause mortality, definite and probable stent thrombosis, myocardial infarction and target lesion revascularization (TLR) at the longest available follow-up. Due to the time point of device approval the longest follow up periods will be around 4 years.

Secondary Outcome Measures

Name	Time	Method
intra-procedural pericardiocentesis rate; post-procedural pericardiocentesis rate; rate of emergency heart surgery; all individual components of the primary safety endpoint