I25.1
Conditions
Interventions
Group 1: Patients implanted with the Papyrus® second-generation covered stent graft system due to peri-procedural coronary artery perforation are documented in a retrospective registry. Data entry is
Sponsors
Studienzentrum der Herzklinik Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients implanted with the Papyrus® second-generation covered stent graft system due to peri-procedural coronary artery perforation.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary effectiveness endpoint: rate of successful closures of coronary perforation Primary safety endpoint: 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
| Measure | Time frame |
|---|---|
| intra-procedural pericardiocentesis rate; post-procedural pericardiocentesis rate; rate of emergency heart surgery; all individual components of the primary safety endpoint | — |
Countries
France, Germany, Netherlands, Poland, South Africa, Sweden, Switzerland
Contacts
Public ContactRalf Birkemeyer
Studienzentrum der Herzklinik Ulm
Outcome results
None listed