The eMESH 1 Feasibility Study

Kips Bay Medical

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

Treatments: Other: Control saphenous vein graft; Device: eSVS Mesh treated saphenous vein graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT01676376

11016 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

eSVS Mesh treated saphenous vein graft

Active Comparator group

Description:

Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.

Treatment:

Device: eSVS Mesh treated saphenous vein graft

Control saphenous vein graft

Sham Comparator group

Description:

Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.

Treatment:

Other: Control saphenous vein graft

Single Vessel Treatment

Active Comparator group

Description:

Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.

Treatment:

Device: eSVS Mesh treated saphenous vein graft