The eSVS® Mesh Post-Marketing Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Kips Bay Medical, Inc.
Sponsor:
Collaborator:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Kips Bay Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01520311
First received: January 3, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Device: eSVS Mesh

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kips Bay Medical, Inc.:

Primary Outcome Measures:
  • Patency and number of stenosis and their degree in eSVS Mesh SVG versus Control SVG [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 Days, 6, 12, and 24 Months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Pre-operative duplex-sonographic evaluation of the in situ saphenous vein graft charicteristics compared to intra-operative venous harvesting records.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: 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.
Other Names:
  • eSVS Mesh
  • eMesh
  • external saphenous vein support mesh

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520311

Contacts
Contact: Oliver Reuthebuch, MD 41 61 265 71 45 reuthebucho@uhbs.ch
Contact: Devdas Inderbitzin, MD 41 61 265 71 45 inderbitzind@uhbs.ch

Locations
Switzerland
University Hospital Recruiting
Basel, Switzerland, CH-4031
Contact: Oliver Reuthebuch, MD    41 61 265 71 45    reuthebucho@uhbs.ch   
Contact: Devdas Inderbitzin, MD    41 61 265 71 45    inderbitzind@uhbs.ch   
Principal Investigator: Oliver Reuthebuch, MD         
Sub-Investigator: Devdas Inderbitzin, MD         
Sponsors and Collaborators
Kips Bay Medical, Inc.
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Oliver Reuthebuch, PD Dr. med University Hospital Basel, Clinic for Cardiac Surgery
Study Chair: Devdas Inderbitzin, MD University Hospital Basel, Clinic for Cardiac Surgery
  More Information

No publications provided

Responsible Party: Kips Bay Medical, Inc.
ClinicalTrials.gov Identifier: NCT01520311     History of Changes
Other Study ID Numbers: PRO-11015.000 or 297/11 v2.0
Study First Received: January 3, 2012
Last Updated: February 27, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kips Bay Medical, Inc.:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
CABG
SVG
eSVS Mesh
Bypass Grafting

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014