Clinical trial NCT02922088: EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC]
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]
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Somahlution LLC
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 2964
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery

Brief 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. 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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Major Adverse Cardiac Events (MACE)
timeFrame: Annually up to 5 years post-CABG Surgery
Secondary outcomes:
measure: Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: Annually up to 5 years post-CABG Surgery
measure: Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 1 month post-CABG Surgery
measure: Quality of life (EQ-5D-5L)
timeFrame: Annually up to 5 years post-CABG Surgery
measure: Health Economics Outcomes
timeFrame: Annually up to 5 years post-CABG Surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Aachen
country: Germany
facility: RWTH Aachen University
city: Berlin
country: Germany
facility: Charité University of Medicine Berlin
city: Berlin
country: Germany
facility: German Heart Center Berlin
city: Cologne
country: Germany
facility: Cologne University Heart Center
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Essen
country: Germany
facility: University Hospital Essen
city: Frankfurt
country: Germany
facility: Goethe University Hospital Frankfurt
city: Giessen
country: Germany
facility: University of Giessen
city: Göttingen
country: Germany
facility: Georg August University of Gottingen
city: Kiel
country: Germany
facility: University Medical Center Schleswig-Holstein
city: Leipzig
country: Germany
facility: Heart Center Leipzig
city: Lübeck
country: Germany
facility: University of Lubeck
city: Marburg
country: Germany
facility: University of Marburg
city: Muenchen
country: Germany
facility: German Heart Center Munich
city: Wuppertal
country: Germany
facility: Helios Clinic Wuppertal Heart Center
city: Cork
country: Ireland
facility: Cork University Hospital
city: Galway
country: Ireland
facility: Galway University Hospitals
city: Roma
country: Italy
facility: European Hospital
city: Badajoz
country: Spain
facility: Complejo Hospitalario Universitario de Badajoz
city: Barakaldo
country: Spain
facility: Cruces University Hospital
city: Cadiz
country: Spain
facility: Hospital Universitario Puerto del Mar
city: Córdoba
country: Spain
facility: Reina Sofia University Hospital
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maran᷉on
city: Madrid
country: Spain
facility: Ruber International Hospital
city: Salamanca
country: Spain
facility: Salamanca University Hospital
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario De Santiago De Compostela
city: Seville
country: Spain
facility: H.U. Virgen del Rocio
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Zürich
country: Switzerland
facility: Herzklinik Hirslanden
city: Zürich
country: Switzerland
facility: University Hospital of Zurich
city: Antalya
country: Turkey
facility: Medical Park Hospital
city: Blackpool
country: United Kingdom
facility: Victoria Blackpool Hospital
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital (Scotland)
Study officials:
affiliation: University Hospital, Zürich
name: Maximillian Emmert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.