The eSVS® Mesh Post-Marketing Trial

NCT ID: NCT01520311

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

eSVS Mesh

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

eMesh; external saphenous vein support mesh

Eligibility Criteria

Inclusion Criteria

• Patients requiring SVG CABG of the Right Coronary Artery (RCA) AND the Circumflex Artery (Cx) Systems due to atherosclerotic coronary artery disease in both of the two vessels with equal to or greater than 75% stenosis at a single site or multiple stenosis of less than 75%
• Patient with approximately sized and accessible target coronary arteries, with a minimal diameter of 1.5mm and a lack of severe calcification at the anastomotic site
• On-pump, off-pump and beating heart (beating heart with cardiopulmonary bypass) CABG.
• SVG's (eSVS Mesh treated AND non-meshed control vein graft) complying with the size requirements as outlined in the eSVS Mesh "Instructions for Use"
• CABG operational procedure must allow an eSVS Mesh implant procedure as to the eSVS Mesh Instructions for Use
• Patients equal to or greater than 21 years of age
• German language (mother tongue or fully comprehensive patients)
• Any other language with appropriate translation (fully comprehensive patients)
• The patient's accordance to CABG confirmed by a signed standardized internal informed consent for CABG
• Patient able to give their informed written consent

Exclusion Criteria

• Patients not able to give their informed written consent
• No appropriate target coronary vessel (impaired accessibility, less than 1.5mm diameter, severe calcification)
• SVG's (eSVS Mesh treated AND non-meshed control venous graft) NOT complying with the size requirements as outlined in the eSVS Mesh Instructions for Use
• CABG operational procedure, that DO NOT ALLOW an eSVS Mesh implant procedure as to the eSVS Mesh Instructions for Use
• Concomitant non-CABG cardiac procedure(s)
• Prior cardiac surgery
• Concomitant disease likely to limit life expectancy to less than 2 years
• inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin)
• Inability to comply with required follow-ups, including angiography imaging methods (allergy to contrast medium, renal insufficiency with creatnine level greater than 150 mmol/l)
• Patients with a known or suspected infection in the field of operation
• Patient is pregnant or intends to become pregnant within 24 months
• Non-pregnant Patient of childbearing potential, who is not prepared for contraception during the study-period
• Concurrent participation in another interventional trial (excluding observational/survey studies)
• Foreign language (no entire comprehension of the patient information and informed study consent guaranteed)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Kips Bay Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Reuthebuch, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Clinic for Cardiac Surgery

Devdas Inderbitzin, MD

Role: STUDY_CHAIR

University Hospital Basel, Clinic for Cardiac Surgery

Locations

University Hospital

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

PRO-11015.000 or 297/11 v2.0

Identifier Type: -

Identifier Source: org_study_id