The eSVS® Mesh Post-Marketing Trial
The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of Duplex Sonography Results and coronary angiography and major cardiovascular or cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.
Coronary Artery Disease
Arterial Occlusive Diseases
Device: eSVS Mesh
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Post-market Study to Evaluate Post-implant Patency Rates of the eSVS Mesh in the Treatment of Saphenous Vein Graphs During Coronary Artery Bypass Grafting Versus Saphenous Vein Grafts Without the eSVS Mesh Via Coronary Angiography and Duplex Ultra-Sonography Results|
- Patency and number of stenosis and their degree in eSVS Mesh SVG versus Control SVG [ Time Frame: 24 Months ] [ Designated as safety issue: No ]Severest degree of graft stenosis (in %; range 0-100) of eSVS Mesh Treated and Non-Meshed control saphenous vein grafts (SVG) assessed by angiography 24 months following CABG.
- Incidence of MACCE [ Time Frame: 30 Days, 6, 12, and 24 Months ] [ Designated as safety issue: Yes ]Incidence of postoperative major adverse cardiac or cerebral events (MACCE): postoperative cerebral stroke, myocardial infarction, (Q wave and non-Q wave), post-implant coronary revascularization (Re-CABG or percutaneous coronary intervention (PCI)) and overall mortality after CABG.
- Evaluation and comparison of vein characteristics of SVGs pre-operatively using duplex-sonography versus intraoperatively by standard vein harvest [ Time Frame: Baseline ] [ Designated as safety issue: No ]Pre-operative duplex-sonographic evaluation of the in situ saphenous vein graft charicteristics compared to intra-operative venous harvesting records.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
SVG + eSVS Mesh vs Control SVG
Either the Circumflex Coronary Artery or the Right Coronary Artery will receive the mesh supported vein graft and the native saphenous vein as second and control graft.
Device: eSVS Mesh
Patients with multi-vessel coronary artery disease who require SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic Coronary Artery Disease will serve as their own control. They will be randomized to either an SVG+eSVS Mesh to the RCA and an SVG to the Cx or an SVG to the RCA and an SVG+eSVS Mesh to the Cx.
This Study will enroll up to 100 patients total. Patients will be enrolled upon meeting certain inclusion criteria, including GSV duplex-sonography results and consent. They will be enrolled based on their clinically indicated requirement for coronary artery bypass grafting with use of their saphenous vein graft. The study will be prospective, randomized repeated measure controlled trial based on the patient's ability to receive both control and eSVS Mesh treatment. Graft patency, MACCE at 6 and 24 months after meshed and non meshed GSV graft implantation will be measured and the findings and qualification of GSV in preoperative duplex sonography will be compared with intraoperative findings while GSV harvesting in order to evaluate the safety of the eSVS mesh and the role of preoperative GSV duplex sonography.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520311
|Basel, Switzerland, CH-4031|
|Principal Investigator:||Oliver Reuthebuch, PD Dr. med||University Hospital Basel, Clinic for Cardiac Surgery|
|Study Chair:||Devdas Inderbitzin, MD||University Hospital Basel, Clinic for Cardiac Surgery|