Coronary Artery DiseasePhase 2eSVSNCT00777777
The eSVS (TM) Mesh External Saphenous Vein Support Trial
A Phase 2 study testing eSVS, saphenous vein supporting mesh in people with Coronary Artery Disease, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- eSVS, saphenous vein supporting mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2008to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
- taking warfarin or clopidogrel at the time of surgery
- inability to comply with required follow-ups, including angiography imaging methods
- patient is pregnant or intends on becoming pregnant in the next 12 months
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
Singapore, 119074
Uwe Klima, MD, PhD, 00656772 ext. 2065, uwe_klima@nuh.com.sg
About this study
Official title: The eSVS(TM)Mesh External Saphenous Vein Support Trial
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.
Read the 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:
- SVG+eSVS™ Mesh at Right Coronary Artery and SVG at Circumflex Artery or
- 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
- Coronary Artery Disease
- Being tested
- eSVS, saphenous vein supporting mesh
- Keywords
- multi-vessel, therapy, surgery, CABG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSVS, saphenous vein supporting meshDevice
Also called eSVS™; Kips Bay Medical
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: eSVS, saphenous vein supporting mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery
Measured: 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
Measured: 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
Measured: 12 months
Per-patient incidence of vein graft failure/occlusion
Measured: 12 months
Per-graft incidence of vein graft failure/occlusion
Measured: 12 months
Rates of graft failure due to characterization of anastomotic site failure vs. graft failure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Kips Bay Medical, Inc., Transmedic Pte Ltd, Singapore
- Investigators
- Uwe Klima, MD, PhD, Principal investigator, Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777777
- Sponsor's protocol ID
- DSRB-C/08/149
- Acronym
- eSVS
- Status last verified
- Oct 2008
- First submitted
- 20 Oct 2008
- Last updated
- 22 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9461200Klesius 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.
PubMed 17992655
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The eSVS(TM)Mesh External Saphenous Vein Support Trial
- ClinicalTrials.gov ID
- NCT00777777
- Acronym / sponsor ID
- eSVS / DSRB-C/08/149
- Conditions
- Coronary Artery Disease
- Keywords
- multi-vessel, therapy, surgery, CABG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Kips Bay Medical, Inc., Transmedic Pte Ltd, Singapore
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- SVG+eSVS™ Mesh at Right Coronary Artery and SVG at Circumflex Artery or
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: eSVS, saphenous vein supporting meshEither 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eSVS, saphenous vein supporting meshAlso: eSVS™; Kips Bay MedicalSurgical 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). | Device | 1 |
Primary outcome
Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery
Time frame: 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
Time frame: 12 months
4 secondary outcomes
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
Time frame: 12 months
Per-patient incidence of vein graft failure/occlusion
Time frame: 12 months
Per-graft incidence of vein graft failure/occlusion
Time frame: 12 months
Rates of graft failure due to characterization of anastomotic site failure vs. graft failure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2008.
- Background: PubMed 9461200Mehta 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.
- Background: PubMed 17992655Klesius 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Klima, MD, PhD principal investigator
Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eSVS, saphenous vein supporting mesh in people with Coronary Artery Disease, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uwe Klima, MD, PhD (00656772 ext. 2065, uwe_klima@nuh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00777777, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2008.