Cardiovascular DiseasesVASCNCT02922088
EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC]
An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Somahlution LLC at 36 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Coronary Artery Disease
- What is being tested?
- DuraGraft
- Type of treatment
- Medical device
- How many people
- 2,964 participants
- Where
- 36 sitesin 8 countries
- Study dates
- 9 Dec 2016to Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery
Who may be able to join
- 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
Who cannot join
- Participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment
Trial locations and contacts
36 sites in 8 countries.
36 sites in 8 countries
Germany15 sites
RWTH Aachen University
Aachen
Charité University of Medicine Berlin
Berlin
German Heart Center Berlin
Berlin
Cologne University Heart Center
Cologne
Herzzentrum Dresden
Dresden
University Hospital Essen
Essen
Goethe University Hospital Frankfurt
Frankfurt
University of Giessen
Giessen
Georg August University of Gottingen
Göttingen
University Medical Center Schleswig-Holstein
Kiel
Heart Center Leipzig
Leipzig
University of Lubeck
Lübeck
University of Marburg
Marburg
German Heart Center Munich
München
Helios Clinic Wuppertal Heart Center
Wuppertal
Spain11 sites
Complejo Hospitalario Universitario de Badajoz
Badajoz
Cruces University Hospital
Barakaldo
Hospital Universitario Puerto del Mar
Cadiz
Reina Sofia University Hospital
Córdoba
Hospital Ramón y Cajal
Madrid
Hospital Universitario Gregorio Maran᷉on
Madrid
Ruber International Hospital
Madrid
Salamanca University Hospital
Salamanca
Hospital Universitario De Santiago De Compostela
Santiago de Compostela
H.U. Virgen del Rocio
Seville
Hospital Universitario Virgen Macarena
Seville
Switzerland3 sites
Cardiocentro Ticino
Lugano
Herzklinik Hirslanden
Zurich
University Hospital of Zurich
Zurich
Ireland2 sites
Cork University Hospital
Cork
Galway University Hospitals
Galway
United Kingdom2 sites
Victoria Blackpool Hospital
Blackpool
Golden Jubilee National Hospital (Scotland)
Clydebank
About this study
Official title: 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.
Read the 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
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease
- Being tested
- DuraGraft
- Keywords
- Vein Graft Failure, Coronary Artery Bypass Graft Surgery, Vascular Grafts, Saphenous Vein Grafts, Vein Graft Disease, Vein Graft Treatment, Vein Graft Handling
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraGraftDevice
DuraGraft is a one-time intraoperative vascular graft treatment designed to prevent graft disease and failure and reduce the clinical complications associated with graft failure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Cardiac Events (MACE)
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.
Measured: Annually up to 5 years post-CABG Surgery
Secondary outcomes (4)
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)
Measured: Annually up to 5 years post-CABG Surgery
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)
Measured: 1 month post-CABG Surgery
Quality of life (EQ-5D-5L)
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.
Measured: Annually up to 5 years post-CABG Surgery
Health Economics Outcomes
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.
Measured: Annually up to 5 years post-CABG Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start9 Dec 2016
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,964 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Somahlution LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maximillian Emmert, MD, Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922088
- Sponsor's protocol ID
- 005-01
- Acronym
- VASC
- Status last verified
- Mar 2021
- First submitted
- 7 Sep 2016
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kim FY, Marhefka G, Ruggiero NJ, Adams S, Whellan DJ. Saphenous vein graft disease: review of pathophysiology, prevention, and treatment. Cardiol Rev. 2013 Mar-Apr;21(2):101-9. doi: 10.1097/CRD.0b013e3182736190.
PubMed 22968180Shukla N, Jeremy JY. Pathophysiology of saphenous vein graft failure: a brief overview of interventions. Curr Opin Pharmacol. 2012 Apr;12(2):114-20. doi: 10.1016/j.coph.2012.01.001. Epub 2012 Feb 8.
PubMed 22321569Thatte HS, Biswas KS, Najjar SF, Birjiniuk V, Crittenden MD, Michel T, Khuri SF. Multi-photon microscopic evaluation of saphenous vein endothelium and its preservation with a new solution, GALA. Ann Thorac Surg. 2003 Apr;75(4):1145-52; discussion 1152. doi: 10.1016/s0003-4975(02)04705-7.
PubMed 12683553Sandner S, Misfeld M, Caliskan E, Boning A, Aramendi J, Salzberg SP, Choi YH, Perrault LP, Tekin I, Cuerpo GP, Lopez-Menendez J, Weltert LP, Bohm J, Krane M, Gonzalez-Santos JM, Tellez JC, Holubec T, Ferrari E, Doros G, Vitarello CJ, Emmert MY; Registry Investigators; European DuraGraft Registry investigators'. Clinical outcomes and quality of life after contemporary isolated coronary bypass grafting: a prospective cohort study. Int J Surg. 2023 Apr 1;109(4):707-715. doi: 10.1097/JS9.0000000000000259.
PubMed 36912566Caliskan E, Misfeld M, Sandner S, Boning A, Aramendi J, Salzberg SP, Choi YH, Perrault LP, Tekin I, Cuerpo GP, Lopez-Menendez J, Weltert LP, Bohm J, Krane M, Gonzalez-Santos JM, Tellez JC, Holubec T, Ferrari E, Emmert MY; European DuraGraft Registry investigators. Clinical event rate in patients with and without left main disease undergoing isolated coronary artery bypass grafting: results from the European DuraGraft Registry. Eur J Cardiothorac Surg. 2022 Sep 2;62(4):ezac403. doi: 10.1093/ejcts/ezac403.
PubMed 35929787Tekin I, Demir M, Ozdem S. Effect of different storage solutions on oxidative stress in human saphenous vein grafts. J Cardiothorac Surg. 2022 Jan 16;17(1):7. doi: 10.1186/s13019-022-01752-7.
PubMed 35034655Caliskan E, Sandner S, Misfeld M, Aramendi J, Salzberg SP, Choi YH, Satishchandran V, Iyer G, Perrault LP, Boning A, Emmert MY. A novel endothelial damage inhibitor for the treatment of vascular conduits in coronary artery bypass grafting: protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry. J Cardiothorac Surg. 2019 Oct 15;14(1):174. doi: 10.1186/s13019-019-1010-z.
PubMed 31615560
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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]
- ClinicalTrials.gov ID
- NCT02922088
- Acronym / sponsor ID
- VASC / 005-01
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease
- Keywords
- Vein Graft Failure, Coronary Artery Bypass Graft Surgery, Vascular Grafts, Saphenous Vein Grafts, Vein Graft Disease, Vein Graft Treatment, Vein Graft Handling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,964 participants (actual)
- Lead sponsor
- Somahlution LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Oct 2016 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment
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 |
|---|---|---|
| DuraGraftDuraGraft is a one-time intraoperative vascular graft treatment designed to prevent graft disease and failure and reduce the clinical complications associated with graft failure. | Device | – |
Primary outcome
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.
4 secondary outcomes
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)
Time frame: 1 month post-CABG Surgery
Quality of life (EQ-5D-5L)
Time frame: Annually up to 5 years post-CABG Surgery
Health Economics Outcomes
Time frame: Annually up to 5 years post-CABG Surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 22968180Kim FY, Marhefka G, Ruggiero NJ, Adams S, Whellan DJ. Saphenous vein graft disease: review of pathophysiology, prevention, and treatment. Cardiol Rev. 2013 Mar-Apr;21(2):101-9. doi: 10.1097/CRD.0b013e3182736190.
- Background: PubMed 22321569Shukla N, Jeremy JY. Pathophysiology of saphenous vein graft failure: a brief overview of interventions. Curr Opin Pharmacol. 2012 Apr;12(2):114-20. doi: 10.1016/j.coph.2012.01.001. Epub 2012 Feb 8.
- Background: PubMed 12683553Thatte HS, Biswas KS, Najjar SF, Birjiniuk V, Crittenden MD, Michel T, Khuri SF. Multi-photon microscopic evaluation of saphenous vein endothelium and its preservation with a new solution, GALA. Ann Thorac Surg. 2003 Apr;75(4):1145-52; discussion 1152. doi: 10.1016/s0003-4975(02)04705-7.
- Derived from this study: PubMed 36912566Sandner S, Misfeld M, Caliskan E, Boning A, Aramendi J, Salzberg SP, Choi YH, Perrault LP, Tekin I, Cuerpo GP, Lopez-Menendez J, Weltert LP, Bohm J, Krane M, Gonzalez-Santos JM, Tellez JC, Holubec T, Ferrari E, Doros G, Vitarello CJ, Emmert MY; Registry Investigators; European DuraGraft Registry investigators'. Clinical outcomes and quality of life after contemporary isolated coronary bypass grafting: a prospective cohort study. Int J Surg. 2023 Apr 1;109(4):707-715. doi: 10.1097/JS9.0000000000000259.
- Derived from this study: PubMed 35929787Caliskan E, Misfeld M, Sandner S, Boning A, Aramendi J, Salzberg SP, Choi YH, Perrault LP, Tekin I, Cuerpo GP, Lopez-Menendez J, Weltert LP, Bohm J, Krane M, Gonzalez-Santos JM, Tellez JC, Holubec T, Ferrari E, Emmert MY; European DuraGraft Registry investigators. Clinical event rate in patients with and without left main disease undergoing isolated coronary artery bypass grafting: results from the European DuraGraft Registry. Eur J Cardiothorac Surg. 2022 Sep 2;62(4):ezac403. doi: 10.1093/ejcts/ezac403.
- Derived from this study: PubMed 35034655Tekin I, Demir M, Ozdem S. Effect of different storage solutions on oxidative stress in human saphenous vein grafts. J Cardiothorac Surg. 2022 Jan 16;17(1):7. doi: 10.1186/s13019-022-01752-7.
- Derived from this study: PubMed 31615560Caliskan E, Sandner S, Misfeld M, Aramendi J, Salzberg SP, Choi YH, Satishchandran V, Iyer G, Perrault LP, Boning A, Emmert MY. A novel endothelial damage inhibitor for the treatment of vascular conduits in coronary artery bypass grafting: protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry. J Cardiothorac Surg. 2019 Oct 15;14(1):174. doi: 10.1186/s13019-019-1010-z.
- Individual participant dataSharing planned: Yes. 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.
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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.
Maximillian Emmert, MD principal investigator
University Hospital, Zürich
36 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Somahlution LLC at 36 sites in 8 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 4 inclusion and 1 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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Germany, Spain, Switzerland, Ireland, United Kingdom and 3 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. 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?
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?
Rate of Major Adverse Cardiac Events (MACE) (time frame: Annually up to 5 years post-CABG Surgery). 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 NCT02922088, which also lists 7 linked publications.
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 18 Mar 2021.