The eSVS (TM) Mesh External Saphenous Vein Support Trial
NCT ID: NCT00777777
Last Updated: 2008-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2008-08-31
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
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.
eSVS, saphenous vein supporting mesh
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
eSVS, saphenous vein supporting mesh
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
21 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kips Bay Medical, Inc.
INDUSTRY
Transmedic Pte Ltd, Singapore
UNKNOWN
National University Hospital, Singapore
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
National University Hospital Singapore
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Uwe Klima, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Uwe Klima, MD, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DSRB-C/08/149
Identifier Type: -
Identifier Source: org_study_id