The eMESH 1 Feasibility Study (eMESH 1)

February 17, 2015 updated by: Kips Bay Medical, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Czech Republic
      • Prague, Czech Republic
        • Recruiting
        • General University Hospital
        • Contact:
          • Jaroslav Lindner, MD
          • Phone Number: +420 224 962 709
        • Principal Investigator:
          • Jaroslav Lindner, MD
      • Prague, Czech Republic
        • Recruiting
        • Hospital Na Homolce
        • Contact:
          • Ivo Skalsky, MD
          • Phone Number: +420257273209
        • Principal Investigator:
          • Ivo Skalsky, MD
      • Prague, Czech Republic
        • Active, not recruiting
        • University Hospital Královské Vinohrady
  • France
      • Limoges, France
        • Recruiting
        • C.H.U. Dupuytren
        • Principal Investigator:
          • Marc Laskar, MD
      • Pessac, France
        • Recruiting
        • Bordeaux University Hospital
        • Principal Investigator:
          • Louis Labrousse, Prof. Dr.
  • Italy
      • Ancona, Italy
        • Recruiting
        • Lancisi Hospital
        • Contact:
          • Giuseppe Rescigno, MD
        • Principal Investigator:
          • Giuseppe Rescigno, MD
      • Massa, Italy
        • Recruiting
        • Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research
        • Principal Investigator:
          • Marco Solinas, MD
        • Sub-Investigator:
          • Michele Murzi, MD
  • Netherlands
      • Eindhoven, Netherlands
        • Recruiting
        • Catharina Ziekenhuis
        • Principal Investigator:
          • Erwin Tan, MD
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • University Hospital of Bern
        • Principal Investigator:
          • Lars Englberger, Dr.
  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Recruiting
        • Royal Brompton Hospital
        • Principal Investigator:
          • Anthony DeSouza, MD
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Principal Investigator:
          • Omar Lattouf, MD
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Northeast Georgia Heart Center
        • Principal Investigator:
          • Alan Wolfe, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic / St. Mary's Hospital
        • Principal Investigator:
          • Lyle Joyce, MD
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • The Valley Hospital
        • Principal Investigator:
          • Juan Grau, MD
        • Contact:
          • Kimberly Michel, RN
          • Phone Number: 2745 201-447-8000
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
          • Nirav Patel, MD
        • Principal Investigator:
          • Nirav Patel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: eSVS Mesh treated saphenous vein graft
Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.
Device: eSVS Mesh treated saphenous vein graft
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.
Sham Comparator: Control saphenous vein graft
Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.
Other: Control saphenous vein graft
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.
Active Comparator: Single Vessel Treatment
Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.
Device: eSVS Mesh treated saphenous vein graft
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
30 days
SVG patency determined by angiography
Time Frame: 6 months
Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.
6 months
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.
intra-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MACCE and mediastinitis
Time Frame: 5 years
MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months.
5 years
SVG patency determined by angiography
Time Frame: 6 months
Angiographic patency rate of the enrolled grafts defined as < 75%.
6 months
Plaque burden
Time Frame: 6 months
Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kips Bay Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lars Englberger, MD, University of Bern
  • Principal Investigator: John Puskas, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11016 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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