EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC]
NCT ID: NCT02922088
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2964 participants
OBSERVATIONAL
2016-12-09
2024-12-31
Brief Summary
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Detailed Description
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(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
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Study Design
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OTHER
PROSPECTIVE
Interventions
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DuraGraft
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Somahlution LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Maximillian Emmert, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Zürich
Locations
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Medical University of Vienna
Vienna, , Austria
RWTH Aachen University
Aachen, , Germany
Charité University of Medicine Berlin
Berlin, , Germany
German Heart Center Berlin
Berlin, , Germany
Cologne University Heart Center
Cologne, , Germany
Herzzentrum Dresden
Dresden, , Germany
University Hospital Essen
Essen, , Germany
Goethe University Hospital Frankfurt
Frankfurt, , Germany
University of Giessen
Giessen, , Germany
Georg August University of Gottingen
Göttingen, , Germany
University Medical Center Schleswig-Holstein
Kiel, , Germany
Heart Center Leipzig
Leipzig, , Germany
University of Lubeck
Lübeck, , Germany
University of Marburg
Marburg, , Germany
German Heart Center Munich
München, , Germany
Helios Clinic Wuppertal Heart Center
Wuppertal, , Germany
Cork University Hospital
Cork, , Ireland
Galway University Hospitals
Galway, , Ireland
European Hospital
Roma, , Italy
Complejo Hospitalario Universitario de Badajoz
Badajoz, , Spain
Cruces University Hospital
Barakaldo, , Spain
Hospital Universitario Puerto del Mar
Cadiz, , Spain
Reina Sofia University Hospital
Córdoba, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario Gregorio Maran᷉on
Madrid, , Spain
Ruber International Hospital
Madrid, , Spain
Salamanca University Hospital
Salamanca, , Spain
Hospital Universitario De Santiago De Compostela
Santiago de Compostela, , Spain
H.U. Virgen del Rocio
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Cardiocentro Ticino
Lugano, , Switzerland
Herzklinik Hirslanden
Zurich, , Switzerland
University Hospital of Zurich
Zurich, , Switzerland
Medical Park Hospital
Antalya, , Turkey (Türkiye)
Victoria Blackpool Hospital
Blackpool, , United Kingdom
Golden Jubilee National Hospital (Scotland)
Clydebank, , United Kingdom
Countries
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References
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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.
Shukla 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.
Thatte 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.
Sandner 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.
Caliskan 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.
Tekin 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.
Caliskan 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.
Other Identifiers
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005-01
Identifier Type: -
Identifier Source: org_study_id
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