The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose vascular grafts have been treated with DuraGraft. All participating sites will be from countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes and patient reported quality of life over a period of 5 years.
Objectives: (i) To evaluate the Safety and Performance of DuraGraft® (ii) To characterize the use of DuraGraft and the outcomes of patients whose vascular grafts were treated with DuraGraft in daily clinical routine (iii) To further characterize the incidence of MACCE outcomes associated with CABG in patients whose vascular grafts were treated with DuraGraft in daily clinical routine (iv) To compare the use of DuraGraft among hospitals and practices (v) To obtain patient reported quality of life information (vi) To obtain important health economics outcomes
Study Type
OBSERVATIONAL
Enrollment
2,964
DuraGraft is a one-time intraoperative vascular graft treatment designed to prevent graft disease and failure and reduce the clinical complications associated with graft failure.
Rate of Major Adverse Cardiac Events (MACE)
Rate of Major Adverse Cardiac Events: MACE (a composite of Death, Non-Fatal Myocardial Infarction and Repeat Revascularization. The rate of MACE will be compared to historical controls.
Time frame: Annually up to 5 years post-CABG Surgery
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)
Time frame: Annually up to 5 years post-CABG Surgery
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)
Time frame: 1 month post-CABG Surgery
Quality of life (EQ-5D-5L)
Quality of life will be measured with EQ-5D-5L (Comprised of 5 questions, each with 5 levels that represent 5 health domains (5D): pain, mood, mobility, self-care and daily activities). This overall self-rated health status will be expressed as an index value.
Time frame: Annually up to 5 years post-CABG Surgery
Health Economics Outcomes
Health economic outcome measures will include the following: * The number (n) of major adverse cardiac and cerebrovascular events (MACCE) will be obtained. * The incidence rate (%) of major adverse cardiac and cerebrovascular events (MACCE) will be obtained * For death: the mortality rate (%) will be obtained. * For non-fatal myocardial infarction, repeat revascularization and stroke: the total number of affected patients (n) will be obtained. * For non-fatal myocardial infarction, repeat revascularization and stroke: the total number of the incidence rate (%) will be obtained. These outcome measures will be used to obtain the total cost of healthcare resource utilization costs for the treatment of post-operative cardiovascular events.
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Medical University of Vienna
Vienna, Austria
RWTH Aachen University
Aachen, Germany
Charité University of Medicine Berlin
Berlin, Germany
German Heart Center Berlin
Berlin, Germany
Cologne University Heart Center
Cologne, Germany
Herzzentrum Dresden
Dresden, Germany
University Hospital Essen
Essen, Germany
Goethe University Hospital Frankfurt
Frankfurt, Germany
University of Giessen
Giessen, Germany
Georg August University of Gottingen
Göttingen, Germany
...and 26 more locations
Time frame: Annually up to 5 years post-CABG Surgery