Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/dissection of the Descending Thoracic Aorta
NCT ID: NCT03735472
Last Updated: 2025-02-19
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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COMPLETED
351 participants
OBSERVATIONAL
2016-04-30
2024-11-30
Brief Summary
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Detailed Description
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Systematic coherence control procedures will be implemented and documented. The correction procedures will be tracked. For the study data, requests (Queries) will be issued and transmitted to the various centres for resolution.
To ensure data quality, a Monitoring Plan will be implemented. This plan will detail the frequency of visits or check-ups and the proportion of the data verified. It is expected that at least 10% of the data will be verified.
The monitoring factors in relation to the quality of electronic case report form completion will be performed by one of the Clinical Research Associates.
The participating physicians will be automatically contacted in the event of the absence of data entry after inclusion of patients and/or dates of scheduled visits and planned controls.
All of the analyses will be managed by the Direction de la Recherche Clinique et de l'Innovation of CHU Amiens. The statistical analysis software to be used is SAS (version 9.1). According to the target population, a sample of approximately 80 to 100 patients is anticipated, which would enable accuracy of ± 8.5 to 9.5% for an estimation of an event rate of around 25%.
During implementation of the study, the observers will be asked to minimise any missing data. The data collected is comparable to usual practice, which should be available from the original medical record. However, in the event of absence of the latter, the note missing data will be added to the data collection form. Several measures will be taken to avoid patients being lost to follow-up.
The study documents provided to the observers for initiation emphasise the fundamental importance of patient follow-up and the collection of data during the entire study. If necessary, scientific societies as well as the French National Authority of Health (HAS) may remind the observers of their obligation to actively participate in the existing national observational study.
The observer will obtain the means to contact the patient, his/her General Practitioner or close friend/next of kin.
Demographic and medical data of patients and follow-up descriptive data will be reflected in the patient population included.
Qualitative parameters are described by their frequency distribution and related bilateral 95% confidence intervals, quantitative parameters by their average, standard deviation minimum, maximum, median and quartiles, number of missing values.
Each of the rates corresponding to the study criteria is analysed by calculating the frequencies of distribution and related bilateral 95% confidence intervals (95% CI).
The rate of events over time will be described by a survival curve using the Kaplan Meier method and the related Kaplan Meier estimators will be calculated.
On an exploratory basis, the criteria in the study will also be analysed according to the basic characteristics of the patients:
* Age (in categories)
* Sex
* Indications.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aneurysm/Dissection
Thoraflex™ Hybrid
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient residing abroad, for whom follow-up is not possible.
* Patient with active endocarditis
* Patient who has received a post-infarction septal repair.
* A list of all of the patients who have received the Thoraflex™ Hybrid hybrid vascular prosthesis but not participating in the observational study will be documented, as well as the reasons for non-inclusion
ALL
No
Sponsors
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Vascutek Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Professor Thierry Caus
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire. Heart, Chest and Vascular Centre, AMIENS
Locations
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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
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, , 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, , France
Clinique Pasteur
Toulouse, , France
CHU De Tours
Tours, , France
Clinique Du Tonkin - Medipole
Villeurbanne, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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EPI-Flex
Identifier Type: -
Identifier Source: org_study_id
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