Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Somahlution LLC
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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment
