Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)Phase 1/2eMESH 1NCT01676376
The eMESH 1 Feasibility Study
A Phase 1/2 study testing eSVS Mesh treated saphenous vein graft in people with Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s), run by Kips Bay Medical, Inc. at 15 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
- What is being tested?
- eSVS Mesh treated saphenous vein graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 15 sitesin 7 countries
- Study dates
- Aug 2012to Jun 2020
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
United States5 sites, 5 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Omar Lattouf, MD
- Recruiting
Northeast Georgia Heart Center
Gainesville, Georgia, 30501
Alan Wolfe, MD
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Nirav Patel, MD
Nirav Patel, MD
- Recruiting
The Valley Hospital
Ridgewood, New Jersey, 07450
Kimberly Michel, RN, 201-447-8000 ext. 2745
Juan Grau, MD
- Recruiting
Mayo Clinic / St. Mary's Hospital
Rochester, Minnesota, 55905
Lyle Joyce, MD
Czechia3 sites, 2 recruiting
- Recruiting
General University Hospital
Prague
Jaroslav Lindner, MD, +420 224 962 709
Jaroslav Lindner, MD
- Recruiting
Hospital na Homolce
Prague
Ivo Skalsky, MD, +420257273209
Ivo Skalsky, MD
- Active, not recruiting
University Hospital Kralovske Vinohrady
Prague
France2 sites, 2 recruiting
- Recruiting
C.H.U. Dupuytren
Limoges
Marc Laskar, MD
- Recruiting
Bordeaux University Hospital
Pessac
Louis Labrousse, Prof. Dr.
Italy2 sites, 2 recruiting
- Recruiting
Lancisi Hospital
Ancona
Giuseppe Rescigno, MD
Giuseppe Rescigno, MD
- Recruiting
Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research
Massa
Marco Solinas, MD
Michele Murzi, MD
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Ziekenhuis
Eindhoven
Erwin Tan, MD
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Bern
Bern, 3010
Lars Englberger, Dr.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London, SW3 6NP
Anthony DeSouza, MD
About this study
Official title: A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study
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.
- Being tested
- eSVS Mesh treated saphenous vein graft, Control saphenous vein graft
- Keywords
- CABG, SVG, nitinol mesh, external saphenous vein graft support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSVS Mesh treated saphenous vein graftDevice
During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
Control saphenous vein graftOther
During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.
| Study group | Role | What they receive |
|---|---|---|
| eSVS Mesh treated saphenous vein graft | Active comparator | Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system. Receives: Device: eSVS Mesh treated saphenous vein graft |
| Control saphenous vein graft | Sham comparator | Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system. Receives: Other: Control saphenous vein graft |
| Single Vessel Treatment | Active comparator | Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system. Receives: Device: eSVS Mesh treated saphenous vein graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG).
Measured: 30 days
SVG patency determined by angiography
Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.
Measured: 6 months
Technical success implanting eSVS Mesh
Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.
Measured: intra-operative
Secondary outcomes (3)
MACCE and mediastinitis
MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months.
Measured: 5 years
SVG patency determined by angiography
Angiographic patency rate of the enrolled grafts defined as < 75%.
Measured: 6 months
Plaque burden
Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2015 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kips Bay Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Englberger, MD, Principal investigator, University of BernJohn Puskas, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676376
- Sponsor's protocol ID
- 11016
- Acronym
- eMESH 1
- Status last verified
- Feb 2015
- First submitted
- 21 Aug 2012
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study
- ClinicalTrials.gov ID
- NCT01676376
- Acronym / sponsor ID
- eMESH 1 / 11016
- Keywords
- CABG, SVG, nitinol mesh, external saphenous vein graft support
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kips Bay Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 30 Aug 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| eSVS Mesh treated saphenous vein graft | Active comparator | Device: eSVS Mesh treated saphenous vein graftEach subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system. |
| Control saphenous vein graft | Sham comparator | Other: Control saphenous vein graftEach subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system. |
| Single Vessel Treatment | Active comparator | Device: eSVS Mesh treated saphenous vein graftEach subject with receive one SVG with eSVS Mesh either to the right or left coronary system. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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%.
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 Mesh treated saphenous vein graftDuring coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system. | Device | Single Vessel Treatment, eSVS Mesh treated saphenous vein graft |
| Control saphenous vein graftDuring coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system. | Other | Control saphenous vein graft |
Primary outcome
MACE
Time frame: 30 days
The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG).
SVG patency determined by angiography
Time frame: 6 months
Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.
Technical success implanting eSVS Mesh
Time frame: intra-operative
Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.
3 secondary outcomes
MACCE and mediastinitis
Time frame: 5 years
SVG patency determined by angiography
Time frame: 6 months
Plaque burden
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
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.
Lars Englberger, MD principal investigator
University of Bern
John Puskas, MD principal investigator
Emory University
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing eSVS Mesh treated saphenous vein graft in people with Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s), run by Kips Bay Medical, Inc. at 15 sites in 7 countries.
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 5 inclusion and 11 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 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Czechia, France, Italy, Netherlands and 2 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Rebecca Wetterling (763-235-3540, clinical@kipsbaymedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2015.