Cardiovascular Diseases, Coronary Artery Disease
Conditions
Keywords
Vein Graft Failure, Coronary Artery Bypass Graft Surgery, Vascular Grafts, Saphenous Vein Grafts, Vein Graft Disease, Vein Graft Treatment, Vein Graft Handling
Brief summary
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.
Detailed description
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
Interventions
DEVICEDuraGraft
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.
Sponsors
Somahlution LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts * Patient is ≥18 years of age * Patient (or a legally authorized representative) is willing and able to provide consent * DuraGraft is being used for the CABG procedure
Exclusion criteria
* Participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Cardiac Events (MACE) | Annually up to 5 years post-CABG Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | Annually up to 5 years post-CABG Surgery | Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke) |
| Quality of life (EQ-5D-5L) | Annually up to 5 years post-CABG Surgery | 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. |
| Health Economics Outcomes | Annually up to 5 years post-CABG Surgery | 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. |
Countries
Austria, Germany, Ireland, Italy, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Outcome results
None listed