The eMESH 1 Feasibility Study

Phase 1

• Conditions: Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
• Interventions: Device: eSVS Mesh treated saphenous vein graft; Other: Control saphenous vein graft

• Registration Number: NCT01676376
• Lead Sponsor: Kips Bay Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-30
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-17
• Last Update Posted: 2015-02-19
• Primary Completion: 2015-12
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eSVS Mesh treated saphenous vein graft	eSVS Mesh treated saphenous vein graft	Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.
Control saphenous vein graft	Control saphenous vein graft	Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.
Single Vessel Treatment	eSVS Mesh treated saphenous vein graft	Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.

Primary Outcome Measures

Name	Time	Method
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).
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.
SVG patency determined by angiography	6 months	Angiographic patency rate of the enrolled grafts defined as \< 50% stenosis.

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (15)

Hospital na Homolce; 🇨🇿 Prague, Czech Republic

University Hospital of Bern; 🇨🇭 Bern, Switzerland

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Northeast Georgia Heart Center; 🇺🇸 Gainesville, Georgia, United States

Mayo Clinic / St. Mary's Hospital; 🇺🇸 Rochester, Minnesota, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

General University Hospital; 🇨🇿 Prague, Czech Republic

University Hospital Kralovske Vinohrady; 🇨🇿 Prague, Czech Republic

C.H.U. Dupuytren; 🇫🇷 Limoges, France

Bordeaux University Hospital; 🇫🇷 Pessac, France

Lancisi Hospital; 🇮🇹 Ancona, Italy

Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research; 🇮🇹 Massa, Italy

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

The Valley Hospital; 🇺🇸 Ridgewood, New Jersey, United States

Royal Brompton Hospital; 🇬🇧 London, United Kingdom