The eSVS® Mesh Post-Marketing Trial

NCT01520311 | Terminated

• 1 other identifier: PRO-11015.000 or 297/11 v2.0
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; CABG; SVG; eSVS Mesh; Bypass Grafting

Outcome Measures

Primary Outcomes (1)

• Patency and number of stenosis and their degree in eSVS Mesh SVG versus Control SVG

  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.

  24 Months

Secondary Outcomes (2)

• Incidence of MACCE

  30 Days, 6, 12, and 24 Months

• Evaluation and comparison of vein characteristics of SVGs pre-operatively using duplex-sonography versus intraoperatively by standard vein harvest

  Baseline

Study Arms (1)

SVG + eSVS Mesh vs Control SVG

OTHER

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

Interventions

eSVS Mesh 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.

Also known as: eMesh, external saphenous vein support mesh

SVG + eSVS Mesh vs Control SVG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kips Bay Medical, Inc.: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

University Hospital

Basel, CH-4031, Switzerland

Location

MeSH Terms

Conditions

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

Study Officials

• Oliver Reuthebuch, PD Dr. med

  University Hospital Basel, Clinic for Cardiac Surgery

  PRINCIPAL INVESTIGATOR

• Devdas Inderbitzin, MD

  University Hospital Basel, Clinic for Cardiac Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 27, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

CH (1)