The eSVS® Mesh Randomized Post-Market Study

Coronary Artery Disease Clinical Trial

Official title:

Post-market Study to Evaluate Post-implant Patency Rates of the External Saphenous Vein Support (eSVS®) Mesh in the Treatment of Saphenous Vein Grafts (SVGs) During Coronary Artery Bypass Grafting (CABG) Versus SVGs Without the eSVS Mesh.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01462721
• Other study ID #: 11-001
• Status: Terminated
• Phase: N/A
• First received: October 26, 2011
• Last updated: February 27, 2014
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Kips Bay Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.

Description:

The study will enroll up to 200 patients at up to 6 sites. Patients will be enrolled upon meeting entrance criteria, including obtaining written informed consent. Eligible patients must be clinically indicated for coronary artery bypass grafting (CABG) using autologous saphenous vein grafts (SVG). The study is a prospective, randomized, repeated measure controlled trial based on each patient receiving one control SVG and one external Saphenous Vein Support (eSVS) Mesh treated SVG. Each patient will be their own control.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient has been diagnosed with multi-vessel coronary artery disease

• Requires Saphenous Vein Graft (SVG) Coronary Artery Bypass Graft (CABG) surgery of the Right Coronary Artery (RCA) and the Circumflex Artery (Cx) systems due to atherosclerotic coronary artery disease

• SVGs (eSVS Mesh AND Control) meet size requirements as outlined in eSVS Mesh Instructions for Use

• eSVS Mesh implant procedure can be performed as outlined in the eSVS Mesh Instructions for Use

• Are able to give their informed consent

Exclusion Criteria:

• Not able to give informed consent

• No appropriate target coronary vessels

• SVGs (eSVS Mesh or Control) do not meet size requirements as outlined in eSVS Mesh Instructions for Use

• eSVS Mesh implant procedure cannot be performed as outlined in the eSVS Mesh Instructions for Use

• Inability to tolerate or comply with normal post-surgical drug regimen

• Inability to comply with required follow-up coronary angiography/CT

Study Design

Allocation: Randomized, Endpoint Classification: 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 saphenous vein graft (SVG) coronary artery bypass graft (CABG) surgery of the Right coronary Artery (RCA) and the Circumflex Artery (Cx) 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
Germany	University Hospital of Kiel	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Kips Bay Medical, Inc.	University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG	Patency of eSVS Mesh and Control SVGs assessed by spiral CT or angiography at 3-6 months following surgery.	3-6 Months	No
Primary	Patency and percent stenosis of the eSVS Mesh and Control Saphenous Vein Grafts	Patency and percent stenosis of the eSVS Mesh and Control SVGs assessed by angiography at 24 months following surgery	24 Months	No
Primary	The occurrence of any Major Adverse Cardiac Event (MACE)	The occurrence of the MACE composite of death, myocardial infarction (Q wave and non-Q wave), stroke, coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention), and at 3 to 6-months postimplant.	3-6 months post implant	Yes