Clinical trial NCT00777777: The eSVS (TM) Mesh External Saphenous Vein Support Trial
Official title: The eSVS(TM)Mesh External Saphenous Vein Support Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: multi-vessel, therapy, surgery, CABG
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Kips Bay Medical, Inc.
name: Transmedic Pte Ltd, Singapore
First posted: 2008-10-22
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, randomized, controlled (patients as their own control) trial on an external mesh device (eSVS™, Kips Bay Medical) supporting saphenous vein grafts for coronary bypass graft surgery in patients with multi-vessel coronary heart disease.

Detailed description: The objective of the eSVS™ Mesh Saphenous Vein Support Trial is to prospectively evaluate the clinical safety and efficacy of the eSVS™ Mesh for the treatment of Saphenous Vein Graft (SVG) Coronary artery bypass grafting (CABG) versus SVG CABG without an eSVS™ Mesh.

The eSVS™ Mesh External Saphenous Vein Support Trial is a prospective, multi-center, randomized, controlled trial enrolling up to 120 patients with multi-vessel coronary artery disease who require SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease. Patients will serve as their own control (patients will be randomized to either:

1. SVG+eSVS™ Mesh at Right Coronary Artery and SVG at Circumflex Artery or
2. SVG at Right Coronary Artery and SVG+eSVS™ Mesh at Circumflex Artery).

Clinical follow-up assessments consisting of a physical exam, laboratory testing, medication review, and adverse event monitoring for all enrolled patients will be performed at 30 days, 6 months and 12 months. In addition, the 12 month follow-up assessment will include angiography.

The investigational device being evaluated in this clinical trial is an External Saphenous Vein Support device, the eSVS™ Mesh.

The eSVS™ Mesh is an extravascular prosthesis consisting of a highly flexible, semi-compliant knitted nitinol mesh tube that is placed over the patient's saphenous vein graft (SVG) during coronary artery bypass grafting (CABG). The eSVS™ Mesh is designed to:

* provide radial support to the vein to prevent graft dilatation
* reduce the vein graft diameter to more closely match target coronary artery diameter
* provide a more uniform lumen
* improve blood flow characteristics
* mitigate the development of intimal hyperplasia and graft stenosis

The eSVS™ Mesh has compliance characteristics comparable to native internal thoracic arteries. Since the eSVS™ Mesh vascular prosthesis is made of nitinol, it is highly kink resistant.

Eligibility criteria: Inclusion Criteria:

1. require on-pump SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease, with ≥ 75% stenosis in each of these vessels
2. have appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and a lack of calcification at the anastomotic site
3. are able to give their informed written consent
4. are ≥ 21 years of age

Exclusion Criteria:

1. no appropriate target coronary vessel
2. discreet attachment of each SVG to the aorta is not possible (non-consecutive or "jump" grafts are excluded)
3. concomitant non-CABG cardiac procedure
4. prior peripheral vascular or cardiac surgery
5. prior stroke
6. history of atrial fibrillation
7. diffuse peripheral vascular disease
8. age \> 80
9. LVEF \< 30% at time of enrollment
10. Insulin-dependent diabetes
11. concurrent participation in another trial
12. concomitant life-threatening disease likely to limit life expectancy to less than 2 years
13. contra-indications to on-pump CABG with cardioplegic arrest (calcified aorta, calcified coronaries, small target vessels)
14. emergency CABG surgery
15. inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin)
16. taking warfarin or clopidogrel at the time of surgery
17. inability to comply with required follow-ups, including angiography imaging methods
18. patient is pregnant or intends on becoming pregnant in the next 12 months

Primary outcomes:
measure: Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery
timeFrame: 12 months
measure: Primary Safety Endpoint: The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at 30 days post surgery
timeFrame: 12 months
Secondary outcomes:
measure: The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at discharge, 6 months and 12 months post surgery
timeFrame: 12 months
measure: Per-patient incidence of vein graft failure/occlusion
timeFrame: 12 months
measure: Per-graft incidence of vein graft failure/occlusion
timeFrame: 12 months
measure: Rates of graft failure due to characterization of anastomotic site failure vs. graft failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
Study officials:
affiliation: Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
name: Uwe Klima, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta D, George SJ, Jeremy JY, Izzat MB, Southgate KM, Bryan AJ, Newby AC, Angelini GD. External stenting reduces long-term medial and neointimal thickening and platelet derived growth factor expression in a pig model of arteriovenous bypass grafting. Nat Med. 1998 Feb;4(2):235-9. doi: 10.1038/nm0298-235.
citation: Klesius AA, Konerding MA, Knez P, Dzemali O, Schmitz-Rixen T, Ackermann H, Moritz A, Kleine P. External stenting with a new polyester mesh reduces neointimal hyperplasia of vein grafts in a sheep model. Int J Artif Organs. 2007 Oct;30(10):930-8. doi: 10.1177/039139880703001011.