eSVSThe eSVS(TM)Mesh External Saphenous Vein Support Trial
eSVS, saphenous vein supporting mesh
Arterial Occlusive Diseases+5
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: August 1, 2008
Actual date on which the first participant was enrolled.The objective of the eSVS™ Mesh Saphenous Vein Support Trial is to prospectively evaluate the clinical safety and efficacy of the eSVS™ Mesh for the treatment of Saphenous Vein Graft (SVG) Coronary artery bypass grafting (CABG) versus SVG CABG without an eSVS™ Mesh. The eSVS™ Mesh External Saphenous Vein Support Trial is a prospective, multi-center, randomized, controlled trial enrolling up to 120 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. Patients will serve as their own control (patients will be randomized to either: 1. SVG+eSVS™ Mesh at Right Coronary Artery and SVG at Circumflex Artery or 2. SVG at Right Coronary Artery and SVG+eSVS™ Mesh at Circumflex Artery). Clinical follow-up assessments consisting of a physical exam, laboratory testing, medication review, and adverse event monitoring for all enrolled patients will be performed at 30 days, 6 months and 12 months. In addition, the 12 month follow-up assessment will include angiography. The investigational device being evaluated in this clinical trial is an External Saphenous Vein Support device, the eSVS™ Mesh. The eSVS™ Mesh is an extravascular prosthesis consisting of a highly flexible, semi-compliant knitted nitinol mesh tube that is placed over the patient's saphenous vein graft (SVG) during coronary artery bypass grafting (CABG). The eSVS™ Mesh is designed to: * provide radial support to the vein to prevent graft dilatation * reduce the vein graft diameter to more closely match target coronary artery diameter * provide a more uniform lumen * improve blood flow characteristics * mitigate the development of intimal hyperplasia and graft stenosis The eSVS™ Mesh has compliance characteristics comparable to native internal thoracic arteries. Since the eSVS™ Mesh vascular prosthesis is made of nitinol, it is highly kink resistant.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 21 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
Singapore, SingaporeOpen Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore in Google Maps