The eSVS (TM) Mesh External Saphenous Vein Support Trial

NCT00777777 | Unknown Phase 2

• 1 other identifier: DSRB-C/08/149
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

multi-vessel, therapy, surgery, CABG

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery

  12 months

• 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

  12 months

Secondary Outcomes (4)

• 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

  12 months

• Per-patient incidence of vein graft failure/occlusion

  12 months

• Per-graft incidence of vein graft failure/occlusion

  12 months

• Rates of graft failure due to characterization of anastomotic site failure vs. graft failure

  12 months

Study Arms (1)

1

EXPERIMENTAL

Either the Circumflex Coronary Artery or the Right Coronary Artery will receive the mesh supported vein graft and the native saphenous vein as second and control graft.

Device: eSVS, saphenous vein supporting mesh

Interventions

eSVS, saphenous vein supporting mesh DEVICE

Surgical coronary artery bypass grafting to the right coronary artery and the circumflex coronary artery with saphenous vein grafts, one will be supported by the eSVS(TM).

Also known as: eSVS™; Kips Bay Medical

1

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• are able to give their informed written consent
• are ≥ 21 years of age

You may not qualify if:

• no appropriate target coronary vessel
• discreet attachment of each SVG to the aorta is not possible (non-consecutive or "jump" grafts are excluded)
• concomitant non-CABG cardiac procedure
• prior peripheral vascular or cardiac surgery
• prior stroke
• history of atrial fibrillation
• diffuse peripheral vascular disease
• age \> 80
• LVEF \< 30% at time of enrollment
• Insulin-dependent diabetes
• concurrent participation in another trial
• concomitant life-threatening disease likely to limit life expectancy to less than 2 years
• contra-indications to on-pump CABG with cardioplegic arrest (calcified aorta, calcified coronaries, small target vessels)
• emergency CABG surgery
• inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin)

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Kips Bay Medical, Inc.: collaborator
• Transmedic Pte Ltd, Singapore: collaborator

Study Sites (1)

Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore

Singapore, 119074, Singapore

RECRUITING

Related Publications (2)

• 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.

  PMID: 9461200 BACKGROUND

• 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.

  PMID: 17992655 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Uwe Klima, MD, PhD

  Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uwe Klima, MD, PhD

CONTACT

00656772; uwe_klima@nuh.com.sg

Theodoros Kofidis, MD, PhD

CONTACT

00656772; surtk@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 22, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 22, 2008

Record last verified: 2008-10

Locations

SG (1)