Clinical trial NCT01462721: The eSVS® Mesh Randomized Post-Market Study
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lead sponsor: Kips Bay Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Schleswig-Holstein
First posted: 2011-10-31
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG
timeFrame: 3-6 Months
measure: Patency and percent stenosis of the eSVS Mesh and Control Saphenous Vein Grafts
timeFrame: 24 Months
measure: The occurrence of any Major Adverse Cardiac Event (MACE)
timeFrame: 3-6 months post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital of Kiel
Study officials:
affiliation: Kips Bay Medical, Inc.
name: Randy LaBounty
role: STUDY_DIRECTOR
References: