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The eSVS® Mesh Post-Marketing Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01520311
Recruitment Status : Terminated (Company closed)
First Posted : January 27, 2012
Last Update Posted : June 29, 2016
Sponsor:
Collaborator:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Kips Bay Medical, Inc.

Tracking Information
First Submitted Date  ICMJE January 3, 2012
First Posted Date  ICMJE January 27, 2012
Last Update Posted Date June 29, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
Patency and number of stenosis and their degree in eSVS Mesh SVG versus Control SVG [ Time Frame: 24 Months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
  • Incidence of MACCE [ Time Frame: 30 Days, 6, 12, and 24 Months ]
    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 ]
    Pre-operative duplex-sonographic evaluation of the in situ saphenous vein graft charicteristics compared to intra-operative venous harvesting records.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The eSVS® Mesh Post-Marketing Trial
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Heart Diseases
  • Cardiovascular Diseases
  • Arteriosclerosis
  • Arterial Occlusive Diseases
  • Vascular Diseases
Intervention  ICMJE 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:
  • eMesh
  • external saphenous vein support mesh
Study Arms  ICMJE 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.
Intervention: Device: eSVS Mesh
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 11, 2015)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2012)
100
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01520311
Other Study ID Numbers  ICMJE PRO-11015.000 or 297/11 v2.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kips Bay Medical, Inc.
Study Sponsor  ICMJE Kips Bay Medical, Inc.
Collaborators  ICMJE University Hospital, Basel, Switzerland
Investigators  ICMJE
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
PRS Account Kips Bay Medical, Inc.
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP