The eSVS® Mesh Post-Marketing Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01520311|
Recruitment Status : Terminated (Company closed)
First Posted : January 27, 2012
Last Update Posted : June 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases||Device: eSVS Mesh||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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.
- Patency and number of stenosis and their degree in eSVS Mesh SVG versus Control SVG [ Time Frame: 24 Months ]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 ]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 ]Pre-operative duplex-sonographic evaluation of the in situ saphenous vein graft charicteristics compared to intra-operative venous harvesting records.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|