EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC]

Study Overview
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Brief Summary
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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
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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

Official Title
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European (EU) Multi-Center Registry to Assess Outcomes in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery: Treatment of Vascular Conduits With DuraGraft®, a Novel Endothelial Damage Inhibitor [VASC]

Conditions
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Cardiovascular Diseases, Coronary Artery Disease

Intervention / Treatment
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* Device: DuraGraft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DuraGraft|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Annually up to 5 years post-CABG Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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. | 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. | Annually up to 5 years post-CABG Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vein Graft Failure, Coronary Artery Bypass Graft Surgery, Vascular Grafts, Saphenous Vein Grafts, Vein Graft Disease, Vein Graft Treatment, Vein Graft Handling