VEST III PMS Clinical Protocol (VEST III)

June 23, 2020 updated by: Vascular Graft Solutions Ltd.
Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the right territory and one or more SVGs to the left territory. Of all vein grafts, one will be selected randomly to receive treatment with VEST and another designated Control.

Study Overview

Status

Status

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

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 (Actual)

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.
184

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.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Austria
      • Innsbruck, Austria
        • Medical University of Innsbruck
      • Vienna, Austria
        • Medical University of Vienna
  • Germany
      • Berlin, Germany
        • German Heart Center
      • Bernau, Germany
        • Immanuel Hospital Bernau. Brandenburg Heart Center
      • Cologne, Germany
        • University Hospital of Cologne
      • Essen, Germany
        • West-German Heart Center Essen University
      • Lübeck, Germany
        • University Medical Center Schleswig-Holstein
      • Trier, Germany
        • Krankenhaus der Barmherzigen Brüder
  • Israel
      • Haifa, Israel
        • Rambam - health care campus
      • Ramat Gan, Israel
        • Sheba Medical center Hospital
  • United Kingdom
      • Blackpool, United Kingdom
        • Blackpool Victoria Hospital
      • Bristol, United Kingdom
        • University Hospitals Bristol
      • Oxford, United Kingdom
        • The John Radcliffe Hospital
      • Southampton, United Kingdom
        • University Hospital Southampton
    • Cambridge
      • Papworth Everard, Cambridge, United Kingdom
        • Papworth Hospital

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient scheduled for on-pump CABG on clinical grounds
  2. Two or more bypass vein grafts bypasses indicated as follows: one (1) for right coronary artery, 1 or more for left coronary arteries and IMA indicated for the LAD on clinical grounds
  3. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed
  4. Ability to give their informed written consent
  5. Ability and willingness to comply with study follow up requirements
  6. Patient is ≥ 18 and ≤ 80 years of age, and has Life expectancy ≥5 years

Exclusion Criteria:

  1. Concomitant non-CABG cardiac procedure
  2. Prior cardiac surgery
  3. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
  4. Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta)
  5. Calcification at the intended anastomotic sites, as assessed upon opening of the chest, before randomization
  6. Severe vein varicosity
  7. Prior debilitating stroke less than 1 year before surgery
  8. Severe renal dysfunction (Cr>2.0 mg/dL or >177 μmol/L)
  9. Women of child bearing age
  10. Concomitant life-threatening disease likely to limit life expectancy to less than 5 years
  11. Indication for Warfarin up to time of surgery
  12. Inability to tolerate or comply with required normal post-operative drug regimen (antiplatelet, statin and beta-blockers) that cannot adequately be controlled.
  13. inability to take aspirin
  14. Contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
  15. Inability to comply with required follow-ups including angiographic and/or CT imaging methods.
  16. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

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
  • Masking: NONE

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.
Experimental: VEST supported
Vein graft supported by VEST
Device: VEST External Support
Procedure: Coronary Artery Bypass Surgery
Other Names:
  • CABG
Active Comparator: Control
Vein grafts unsupported by VEST
Procedure: Coronary Artery Bypass Surgery
Other Names:
  • CABG

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
Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones.
Time Frame: 2 years
Perfect patency, no lumen irregularities. Rates out of all grafts including occluded ones.
2 years

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
Intimal hyperplasia area
Time Frame: 2 years
Sub group (IVUS) - Intimal hyperplasia (plaque+media) area [mm2] as assessed by IVUS
2 years
MACCE
Time Frame: 2 years
Composite of: All-cause mortality; Stroke; Myocardial infarction; Coronary revascularization
2 years
Vein graft failure
Time Frame: 2 years
Defined as ≥50% stenosis by QCA
2 years
Early vein graft failure
Time Frame: 6 months
Early vein graft failure, defined as >50% occlusion by CT Angio
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.
Vascular Graft Solutions Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
October 19, 2015

Primary Completion (Actual)

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.
June 1, 2019

Study Completion (Actual)

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.
October 1, 2019

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).
July 25, 2015

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.
July 27, 2015

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.
July 30, 2015

Study Record Updates

Last Update Posted (Actual)

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.
June 26, 2020

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.
June 23, 2020

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.
June 1, 2020

More Information

Terms related to this study

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.
  • CD0113

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings