EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] (VASC)

March 17, 2021 updated by: Somahlution LLC

European (EU) Multi-Center Registry to Assess Outcomes in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery: Treatment of Vascular Conduits With DuraGraft®, a Novel Endothelial Damage Inhibitor [VASC]

The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose vascular grafts have been treated with DuraGraft. All participating sites will be from countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes and patient reported quality of life over a period of 5 years.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

(i) To evaluate the Safety and Performance of DuraGraft®

(ii) To characterize the use of DuraGraft and the outcomes of patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iii) To further characterize the incidence of MACCE outcomes associated with CABG in patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iv) To compare the use of DuraGraft among hospitals and practices

(v) To obtain patient reported quality of life information

(vi) To obtain important health economics outcomes

Study Type

Observational

Enrollment (Actual)

2964

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
      • Vienna, Austria
        • Medical University of Vienna
  • Germany
      • Aachen, Germany
        • RWTH Aachen University
      • Berlin, Germany
        • Charité University of Medicine Berlin
      • Berlin, Germany
        • German Heart Center Berlin
      • Cologne, Germany
        • Cologne University Heart Center
      • Dresden, Germany
        • Herzzentrum Dresden
      • Essen, Germany
        • University Hospital Essen
      • Frankfurt, Germany
        • Goethe University Hospital Frankfurt
      • Giessen, Germany
        • University of Gießen
      • Göttingen, Germany
        • Georg August University of Gottingen
      • Kiel, Germany
        • University Medical Center Schleswig-Holstein
      • Leipzig, Germany
        • Heart Center Leipzig
      • Lübeck, Germany
        • University of Lübeck
      • Marburg, Germany
        • University of Marburg
      • Muenchen, Germany
        • German Heart Center Munich
      • Wuppertal, Germany
        • Helios Clinic Wuppertal Heart Center
  • Ireland
      • Cork, Ireland
        • Cork University Hospital
      • Galway, Ireland
        • Galway University Hospitals
  • Italy
      • Roma, Italy
        • European Hospital
  • Spain
      • Badajoz, Spain
        • Complejo Hospitalario Universitario de Badajoz
      • Barakaldo, Spain
        • Cruces University Hospital
      • Cadiz, Spain
        • Hospital Universitario Puerto Del Mar
      • Córdoba, Spain
        • Reina Sofia University Hospital
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario Gregorio Maran᷉on
      • Madrid, Spain
        • Ruber International Hospital
      • Salamanca, Spain
        • Salamanca University Hospital
      • Santiago De Compostela, Spain
        • Hospital Universitario de Santiago de Compostela
      • Seville, Spain
        • Hospital Universitario Virgen Macarena
      • Seville, Spain
        • H.U. Virgen del Rocio
  • Switzerland
      • Lugano, Switzerland
        • Cardiocentro Ticino
      • Zürich, Switzerland
        • University Hospital of Zürich
      • Zürich, Switzerland
        • Herzklinik Hirslanden
  • Turkey
      • Antalya, Turkey
        • Medical Park Hospital
  • United Kingdom
      • Blackpool, United Kingdom
        • Victoria Blackpool Hospital
      • Clydebank, United Kingdom
        • Golden Jubilee National Hospital (Scotland)

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery

Description

Inclusion Criteria:

  • Patient undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts
  • Patient is ≥18 years of age
  • Patient (or a legally authorized representative) is willing and able to provide consent
  • DuraGraft is being used for the CABG procedure

Exclusion Criteria:

  • Participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment

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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Major Adverse Cardiac Events (MACE)
Time Frame: Annually up to 5 years post-CABG Surgery
Rate of Major Adverse Cardiac Events: MACE (a composite of Death, Non-Fatal Myocardial Infarction and Repeat Revascularization. The rate of MACE will be compared to historical controls.
Annually up to 5 years post-CABG Surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time Frame: Annually up to 5 years post-CABG Surgery
Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)
Annually up to 5 years post-CABG Surgery
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time Frame: 1 month post-CABG Surgery
Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)
1 month post-CABG Surgery
Quality of life (EQ-5D-5L)
Time Frame: Annually up to 5 years post-CABG Surgery
Quality of life will be measured with EQ-5D-5L (Comprised of 5 questions, each with 5 levels that represent 5 health domains (5D): pain, mood, mobility, self-care and daily activities). This overall self-rated health status will be expressed as an index value.
Annually up to 5 years post-CABG Surgery
Health Economics Outcomes
Time Frame: Annually up to 5 years post-CABG Surgery

Health economic outcome measures will include the following:

  • The number (n) of major adverse cardiac and cerebrovascular events (MACCE) will be obtained.
  • The incidence rate (%) of major adverse cardiac and cerebrovascular events (MACCE) will be obtained
  • For death: the mortality rate (%) will be obtained.
  • For non-fatal myocardial infarction, repeat revascularization and stroke: the total number of affected patients (n) will be obtained.
  • For non-fatal myocardial infarction, repeat revascularization and stroke: the total number of the incidence rate (%) will be obtained.

These outcome measures will be used to obtain the total cost of healthcare resource utilization costs for the treatment of post-operative cardiovascular events.
Annually up to 5 years post-CABG Surgery

Collaborators and Investigators

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

Sponsor

Somahlution LLC

Investigators

  • Principal Investigator: Maximillian Emmert, MD, University Hospital, Zürich

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)

December 9, 2016

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Plan to share data to be determined. A Registry Advisory Committee (RAC) will be formed to provide overall scientific direction for the Registry. A publications sub-committee, composed of a subset of the RAC is planned. This sub-committee will be responsible for overseeing the review and approval of all presentations and all publications related to the DuraGraft Registry.

IPD Sharing Time Frame

February 2025

IPD Sharing Access Criteria

To be determined

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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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