Clinical trial NCT01676376: The eMESH 1 Feasibility Study
Official title: A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
Keywords: CABG
SVG
nitinol mesh
external saphenous vein graft support
Lead sponsor: Kips Bay Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: MACE
timeFrame: 30 days
measure: SVG patency determined by angiography
timeFrame: 6 months
measure: Technical success implanting eSVS Mesh
timeFrame: intra-operative
Secondary outcomes:
measure: MACCE and mediastinitis
timeFrame: 5 years
measure: SVG patency determined by angiography
timeFrame: 6 months
measure: Plaque burden
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic / St. Mary's Hospital
state: Minnesota
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Prague
country: Czech Republic
facility: General University Hospital
city: Prague
country: Czech Republic
facility: Hospital na Homolce
city: Prague
country: Czech Republic
facility: University Hospital Kralovske Vinohrady
city: Limoges
country: France
facility: C.H.U. Dupuytren
city: Pessac
country: France
facility: Bordeaux University Hospital
city: Ancona
country: Italy
facility: Lancisi Hospital
city: Massa
country: Italy
facility: Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Bern
country: Switzerland
facility: University Hospital of Bern
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: University of Bern
name: Lars Englberger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: John Puskas, MD
role: PRINCIPAL_INVESTIGATOR
References: