Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
Conditions
Keywords
CABG, SVG, nitinol mesh, external saphenous vein graft support
Brief summary
Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.
Interventions
DEVICEeSVS Mesh treated saphenous vein graft
During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
OTHERControl saphenous vein graft
During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.
Sponsors
Kips Bay Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Randomized Cohort: Requires CABG surgery with a SVG to the right coronary artery (RCA) system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each of the two systems. * Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCX system with a \> 70% stenosis in the system. * Medial sternotomy with cardiopulmonary bypass (CPB) during surgery. * Both saphenous vein graft length are adequate for planned intervention, vein outer diameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm. * Agreement to post-procedure follow-up contact and testing (including follow-up coronary angiogram).
Exclusion criteria
* Concomitant non-CABG cardiac procedure. * Prior cardiac surgery (does not include percutaneous procedures). * Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure. * Age \> 85 years. * Left ventricular ejection fraction ≤ 35%. * Creatinine \> 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis. * STEMI within 7 days or total CK \> 2 times the upper limit of normal prior to the CABG procedure. * Both enrolled grafts will feed non-viable myocardial territory. * Diffuse atherosclerotic disease (\> 70%) distal to either of the enrolled target coronary arteries. * Randomized Cohort: By visual estimate, the target coronary artery diameter of both the right coronary system and left circumflex system must be within 1.5mm of each other. * Planned endarterectomy of the target coronary artery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 30 days | The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG). |
| SVG patency determined by angiography | 6 months | Angiographic patency rate of the enrolled grafts defined as \< 50% stenosis. |
| Technical success implanting eSVS Mesh | intra-operative | Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACCE and mediastinitis | 5 years | MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months. |
| SVG patency determined by angiography | 6 months | Angiographic patency rate of the enrolled grafts defined as \< 75%. |
| Plaque burden | 6 months | Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study). |
Countries
Czechia, France, Italy, Netherlands, Switzerland, United Kingdom, United States
Contacts
Primary ContactRebecca Wetterling
Outcome results
None listed