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Coronary Artery DiseaseNCT01520311

The eSVS® Mesh Post-Marketing Trial

A study testing eSVS Mesh in people with Coronary Artery Disease and Myocardial Ischemia, run by Kips Bay Medical, Inc. at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of Duplex Sonography Results and coronary angiography and major cardiovascular or cerebrovascular event (MACCE)-Rate as well as analysis… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
eSVS Mesh
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteSwitzerland
Study dates
Jan 2012to Sep 2015
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients requiring SVG CABG of the Right Coronary Artery (RCA) AND the Circumflex Artery (Cx) Systems due to atherosclerotic coronary artery disease in both of the two vessels with equal to or greater than 75% stenosis at a single site or multiple stenosis of less than 75%
  • Patient with approximately sized and accessible target coronary arteries, with a minimal diameter of 1.5mm and a lack of severe calcification at the anastomotic site
  • On-pump, off-pump and beating heart (beating heart with cardiopulmonary bypass) CABG.
  • SVG's (eSVS Mesh treated AND non-meshed control vein graft) complying with the size requirements as outlined in the eSVS Mesh "Instructions for Use"
  • CABG operational procedure must allow an eSVS Mesh implant procedure as to the eSVS Mesh Instructions for Use
  • Patients equal to or greater than 21 years of age
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  • German language (mother tongue or fully comprehensive patients)
  • Any other language with appropriate translation (fully comprehensive patients)
  • The patient's accordance to CABG confirmed by a signed standardized internal informed consent for CABG
  • Patient able to give their informed written consent

Who cannot join

  • Patients not able to give their informed written consent
  • No appropriate target coronary vessel (impaired accessibility, less than 1.5mm diameter, severe calcification)
  • SVG's (eSVS Mesh treated AND non-meshed control venous graft) NOT complying with the size requirements as outlined in the eSVS Mesh Instructions for Use
  • CABG operational procedure, that DO NOT ALLOW an eSVS Mesh implant procedure as to the eSVS Mesh Instructions for Use
  • Concomitant non-CABG cardiac procedure(s)
  • Prior cardiac surgery
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  • Concomitant disease likely to limit life expectancy to less than 2 years
  • inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin)
  • Inability to comply with required follow-ups, including angiography imaging methods (allergy to contrast medium, renal insufficiency with creatnine level greater than 150 mmol/l)
  • Patients with a known or suspected infection in the field of operation
  • Patient is pregnant or intends to become pregnant within 24 months
  • Non-pregnant Patient of childbearing potential, who is not prepared for contraception during the study-period
  • Concurrent participation in another interventional trial (excluding observational/survey studies)
  • Foreign language (no entire comprehension of the patient information and informed study consent guaranteed)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital

    Basel, CH-4031

Other trials in Switzerland

About this study

Official title: Post-market Study to Evaluate Post-implant Patency Rates of the eSVS Mesh in the Treatment of Saphenous Vein Graphs During Coronary Artery Bypass Grafting Versus Saphenous Vein Grafts Without the eSVS Mesh Via Coronary Angiography and Duplex Ultra-Sonography Results

The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of Duplex Sonography Results and coronary angiography and major cardiovascular or cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.

Read the detailed description

This Study will enroll up to 100 patients total. Patients will be enrolled upon meeting certain inclusion criteria, including GSV duplex-sonography results and consent. They will be enrolled based on their clinically indicated requirement for coronary artery bypass grafting with use of their saphenous vein graft. The study will be prospective, randomized repeated measure controlled trial based on the patient's ability to receive both control and eSVS Mesh treatment. Graft patency, MACCE at 6 and 24 months after meshed and non meshed GSV graft implantation will be measured and the findings and qualification of GSV in preoperative duplex sonography will be compared with intraoperative findings while GSV harvesting in order to evaluate the safety of the eSVS mesh and the role of preoperative GSV duplex sonography.

Being tested
eSVS Mesh
Keywords
Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases, CABG, SVG, eSVS Mesh, Bypass Grafting
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eSVS MeshDevice

    Also called eMesh, external saphenous vein support mesh

    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 will serve as their own control. They will be randomized to either an SVG+eSVS Mesh to the RCA and an SVG to the Cx or an SVG to the RCA and an SVG+eSVS Mesh to the Cx.

Study groups in NCT01520311
Study groupRoleWhat they receive
SVG + eSVS Mesh vs Control SVGOtherEither 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 Mesh

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patency and number of stenosis and their degree in eSVS Mesh SVG versus Control SVG

    Severest degree of graft stenosis (in %; range 0-100) of eSVS Mesh Treated and Non-Meshed control saphenous vein grafts (SVG) assessed by angiography 24 months following CABG.

    Measured: 24 Months

Secondary outcomes (2)

  1. Incidence of MACCE

    Incidence of postoperative major adverse cardiac or cerebral events (MACCE): postoperative cerebral stroke, myocardial infarction, (Q wave and non-Q wave), post-implant coronary revascularization (Re-CABG or percutaneous coronary intervention (PCI)) and overall mortality after CABG.

    Measured: 30 Days, 6, 12, and 24 Months

  2. Evaluation and comparison of vein characteristics of SVGs pre-operatively using duplex-sonography versus intraoperatively by standard vein harvest

    Pre-operative duplex-sonographic evaluation of the in situ saphenous vein graft charicteristics compared to intra-operative venous harvesting records.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionSep 2015
  4. Study completionSep 2015

Why it stopped: Company closed

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01520311
Sponsor's protocol ID
PRO-11015.000 or 297/11 v2.0
Status last verified
Jun 2016
First submitted
3 Jan 2012
Last updated
29 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing eSVS Mesh in people with Coronary Artery Disease and Myocardial Ischemia, run by Kips Bay Medical, Inc. at 1 site in Switzerland.

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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 29 Jun 2016. 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 Switzerland. 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.

Are results available for this study?

The study was stopped early (reason given: Company closed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patency and number of stenosis and their degree in eSVS Mesh SVG versus Control SVG (time frame: 24 Months). 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 NCT01520311.

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 29 Jun 2016.

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