The eSVS® Mesh Randomized Post-Market Study

Kips Bay Medical, Inc.12 enrolled

Overview

The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.

The study will enroll up to 200 patients at up to 6 sites. Patients will be enrolled upon meeting entrance criteria, including obtaining written informed consent. Eligible patients must be clinically indicated for coronary artery bypass grafting (CABG) using autologous saphenous vein grafts (SVG). The study is a prospective, randomized, repeated measure controlled trial based on each patient receiving one control SVG and one external Saphenous Vein Support (eSVS) Mesh treated SVG. Each patient will be their own control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

Interventions

eSVS® MeshDEVICE

Patients with multi-vessel coronary artery disease who require saphenous vein graft (SVG) coronary artery bypass graft (CABG) surgery of the Right coronary Artery (RCA) and the Circumflex Artery (Cx) 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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has been diagnosed with multi-vessel coronary artery disease * Requires Saphenous Vein Graft (SVG) Coronary Artery Bypass Graft (CABG) surgery of the Right Coronary Artery (RCA) and the Circumflex Artery (Cx) systems due to atherosclerotic coronary artery disease * SVGs (eSVS Mesh AND Control) meet size requirements as outlined in eSVS Mesh Instructions for Use * eSVS Mesh implant procedure can be performed as outlined in the eSVS Mesh Instructions for Use * Are able to give their informed consent Exclusion Criteria: * Not able to give informed consent * No appropriate target coronary vessels * SVGs (eSVS Mesh or Control) do not meet size requirements as outlined in eSVS Mesh Instructions for Use * eSVS Mesh implant procedure cannot be performed as outlined in the eSVS Mesh Instructions for Use * Inability to tolerate or comply with normal post-surgical drug regimen * Inability to comply with required follow-up coronary angiography/CT

Locations (1)

University Hospital of Kiel

Kiel, Germany

Outcomes

Primary Outcomes

Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG

Patency of eSVS Mesh and Control SVGs assessed by spiral CT or angiography at 3-6 months following surgery.

Time frame: 3-6 Months

Patency and percent stenosis of the eSVS Mesh and Control Saphenous Vein Grafts

Patency and percent stenosis of the eSVS Mesh and Control SVGs assessed by angiography at 24 months following surgery

Time frame: 24 Months

The occurrence of any Major Adverse Cardiac Event (MACE)

The occurrence of the MACE composite of death, myocardial infarction (Q wave and non-Q wave), stroke, coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention), and at 3 to 6-months postimplant.

Time frame: 3-6 months post implant

Data from ClinicalTrials.gov

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