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The eSVS® Mesh Post-Marketing Trial

Primary Purpose

Coronary Artery Disease, Myocardial Ischemia, Coronary Disease

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
eSVS Mesh
Sponsored by
Kips Bay Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases, CABG, SVG, eSVS Mesh, Bypass Grafting

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SVG + eSVS Mesh vs Control SVG

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of MACCE
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
Pre-operative duplex-sonographic evaluation of the in situ saphenous vein graft charicteristics compared to intra-operative venous harvesting records.

Full Information

First Posted
January 3, 2012
Last Updated
June 28, 2016
Sponsor
Kips Bay Medical, Inc.
Collaborators
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01520311
Brief Title
The eSVS® Mesh Post-Marketing Trial
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Company closed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kips Bay Medical, Inc.
Collaborators
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SVG + eSVS Mesh vs Control SVG
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
eSVS Mesh
Other Intervention Name(s)
eMesh, external saphenous vein support mesh
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patency and number of stenosis and their degree in eSVS Mesh SVG versus Control SVG
Description
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.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Incidence of MACCE
Description
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.
Time Frame
30 Days, 6, 12, and 24 Months
Title
Evaluation and comparison of vein characteristics of SVGs pre-operatively using duplex-sonography versus intraoperatively by standard vein harvest
Description
Pre-operative duplex-sonographic evaluation of the in situ saphenous vein graft charicteristics compared to intra-operative venous harvesting records.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Reuthebuch, PD Dr. med
Organizational Affiliation
University Hospital Basel, Clinic for Cardiac Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Devdas Inderbitzin, MD
Organizational Affiliation
University Hospital Basel, Clinic for Cardiac Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland

12. IPD Sharing Statement

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The eSVS® Mesh Post-Marketing Trial

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