National Observational Study of the Thoraflex™ Hybrid Vascular Prosthesis in the Replacement of the Aortic Arch and the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta
Sponsor study identifier
observational
351
1 country
37
Study Start
April 2016
Actual (reported)Primary Completion
May 2019
Actual (reported)Study Completion
November 2024
Actual (reported)The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation to morbidity-mortality, visceral malperfusions, neurological and renal complications, endoleak and evolution of the aortic thoracic stent over time.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2015
Actual (reported)April 2016
Actual (reported)November 8, 2018
Actual (reported)May 2019
Actual (reported)November 2024
Actual (reported)Patients who did not die, nor suffered paraplegia due to the prosthesis, nor had complications linked to the procedure and surgical conversion
Percentage of patients who did not die, nor suffered paraplegia due to the prosthesis, nor had complications linked to the procedure and surgical conversion for 30 days post-operative
30 days post-operative
Technical success
Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Death
Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Transitory paraplegia/Para-paresis
Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Follow-up surgery
Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Complications linked to the device
Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Thoraflex™ Hybrid
The Thoraflex™ Hybrid device is particularly suited to the treatment of extended lesions of the ascending aorta, the aortic arch and the descending aorta, which constitute a major challenge in cardiovascular surgery. It enables, during a single surgical operation, combination of the "Frozen Elephant Trunk" technique and a 4-branch prosthesis of the aortic arch, thus enhancing the arsenal of the surgeon in the treatment of complex diseases of the aortic arch.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Any patient presenting an aneurysm/dissection of the thoracic aorta of the aortic arch and/or the descending thoracic aorta and necessitating surgery of the Elephant Trunk type. To meet the requirements of the French National Authority for Health, this study will include all the patients treated with the Thoraflex™ Hybrid hybrid vascular prosthesis. Any surgeon practising in France and wishing to inplant a Thoraflex™ Hybrid hybrid vascular prosthesis will be available from the coordinating observer.
Centre Hospitalier University (University Hospital centre)
Amiens, France
CHU Angers
Angers, France
CH De La Region D Annecy
Annecy, France
CHU-Hopital Jean Minjoz
Besançon, France
Hopital Cardio-Vasculaire Louise Pradel
Bron, France
CHU Cote De Nacre
Caen, France
CHU - Hopital Gabriel Montpied
Clermont-Ferrand, France
Arko FR, Lee WA, Hill BB, Olcott C 4th, Harris EJ, Dalman RL, Fogarty TJ, Zarins CK. Impact of endovascular repair on open aortic aneurysm surgical training. J Vasc Surg. 2001 Nov;34(5):885-91. doi: 10.1067/mva.2001.118816.
Karck M, Chavan A, Hagl C, Friedrich H, Galanski M, Haverich A. The frozen elephant trunk technique: a new treatment for thoracic aortic aneurysms. J Thorac Cardiovasc Surg. 2003 Jun;125(6):1550-3. doi: 10.1016/s0022-5223(03)00045-x. No abstract available.
Professor Thierry Caus
Centre Hospitalier Universitaire. Heart, Chest and Vascular Centre, AMIENS
351 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2015
First Posted
November 8, 2018
Study Start
April 2016
Actual (reported)Contact the study team to confirm eligibility.
CHU Hopital Henri Mondor
Créteil, France
CHU - Hopital Du Bocage
Dijon, France
CHU Hopital A. Michallon
Grenoble, France
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France
CHRU Lille
Lille, France
Clinique De La Sauvegarde
Lyon, France
CHU Hopital La Timone
Marseille, France
Hopital Clinique Claude Bernard
Metz, France
Hopital De Mercy
Metz, France
CHU Hopital Arnaud De Villeneuve
Montpellier, France
CHU - Hopital Brabois
Nancy, France
CHU - Hopital Guillaume et Rene Laenec
Nantes, France
Hopital Prive Les Franciscaines
Nîmes, France
Groupe Hospitalier Pitié-Salpêtrière, Vascular Surgery Department
Paris, 75013, France
Groupe Hospitalier La Pitie Salpetriere
Paris, France
Hopital Bichat
Paris, France
Hopital Europeen Georges Pompidou
Paris, France
Institut Mutualiste Montsouris
Paris, France
CHU - Hopital Haut Leveque
Pessac, France
CHU - Hopital Robert Debre
Reims, France
CHU - Hopital Pontchaillou
Rennes, France
CHU Charles Nicolle
Rouen, France
Centre Cardiologique Du Nord
Saint-Denis, France
CH Felix Guyon
Saint-Denis, France
CHU De Saint Etienne
Saint-Etienne, France
Hopitaux Universitaires - Nouvel Hopital Civil
Strasbourg, France
Hôpital Rangueil, Cardiothoracic Surgery Department
Toulouse, 31009, France
Clinique Pasteur
Toulouse, France
CHU De Tours
Tours, France
Clinique Du Tonkin - Medipole
Villeurbanne, France
Usui A, Ueda Y, Watanabe T, Kawaguchi O, Ohara Y, Takagi Y, Tajima K, Nishikimi N, Ishiguchi T. Clinical results of implantation of an endovascular covered stent-graft via midsternotomy for distal aortic arch aneurysm. Cardiovasc Surg. 2000 Dec;8(7):545-9. doi: 10.1016/s0967-2109(00)00066-1.
Karck M, Kamiya H. Progress of the treatment for extended aortic aneurysms; is the frozen elephant trunk technique the next standard in the treatment of complex aortic disease including the arch? Eur J Cardiothorac Surg. 2008 Jun;33(6):1007-13. doi: 10.1016/j.ejcts.2008.02.030. Epub 2008 Apr 10.
Shrestha M, Pichlmaier M, Martens A, Hagl C, Khaladj N, Haverich A. Total aortic arch replacement with a novel four-branched frozen elephant trunk graft: first-in-man results. Eur J Cardiothorac Surg. 2013 Feb;43(2):406-10. doi: 10.1093/ejcts/ezs296. Epub 2012 May 31.
Patel AY, Eagle KA, Vaishnava P. Acute type B aortic dissection: insights from the International Registry of Acute Aortic Dissection. Ann Cardiothorac Surg. 2014 Jul;3(4):368-74. doi: 10.3978/j.issn.2225-319X.2014.07.06.
Tsai TT, Trimarchi S, Nienaber CA. Acute aortic dissection: perspectives from the International Registry of Acute Aortic Dissection (IRAD). Eur J Vasc Endovasc Surg. 2009 Feb;37(2):149-59. doi: 10.1016/j.ejvs.2008.11.032. Epub 2008 Dec 20.
Jakob H, Tsagakis K. International E-vita open registry. Ann Cardiothorac Surg. 2013 May;2(3):296-9. doi: 10.3978/j.issn.2225-319X.2013.03.10.
Bortone AS, Schena S, D'Agostino D, Dialetto G, Paradiso V, Mannatrizio G, Fiore T, Cotrufo M, de Luca Tupputi Schinosa L. Immediate versus delayed endovascular treatment of post-traumatic aortic pseudoaneurysms and type B dissections: retrospective analysis and premises to the upcoming European trial. Circulation. 2002 Sep 24;106(12 Suppl 1):I234-40.
Primary Completion
May 2019
Actual (reported)Study Completion
November 2024
Actual (reported)Last Updated
February 19, 2025
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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