The eSVS® Mesh Post-Marketing Trial

Coronary Artery Disease Clinical 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01520311
• Other study ID #: PRO-11015.000 or 297/11 v2.0
• Status: Terminated
• Phase: N/A
• First received: January 3, 2012
• Last updated: June 28, 2016
• Start date: January 2012
• Est. completion date: September 2015

Study information

• Verified date: June 2016
• Source: Kips Bay Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Kips Bay Medical, Inc.	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	30 Days, 6, 12, and 24 Months	Yes
Secondary	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.	Baseline	No