Clinical trial NCT03735472: Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/dissection of the Descending Thoracic Aorta
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Arch; Aneurysm, Dissecting
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-08
Enrollment: 351
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: Quality control will be performed continuously at various stages of the error correction process, according to the sponsor's Standard Operating Procedures.

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.

Eligibility criteria: Inclusion Criteria:

• Patient presenting an aneurysm/dissection of the thoracic aorta of the aortic arch and/or the descending thoracic aorta, and necessitating a procedure of the "Elephant Trunk" type, with the Thoraflex™ Hybrid hybrid vascular prosthesis.

Exclusion Criteria:

* Patient having refused to sign the Consent form to the use of his/her data.
* 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

Primary outcomes:
measure: Patients who did not die, nor suffered paraplegia due to the prosthesis, nor had complications linked to the procedure and surgical conversion
timeFrame: 30 days post-operative
Secondary outcomes:
measure: Technical success
timeFrame: Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
measure: Death
timeFrame: Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
measure: Transitory paraplegia/Para-paresis
timeFrame: Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
measure: Follow-up surgery
timeFrame: Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
measure: Complications linked to the device
timeFrame: Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
measure: Rates of visceral malperfusion, neurological, renal, cardiac, respiratory and Haemorrhagic complications
timeFrame: Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier University (University Hospital centre)
city: Angers
country: France
facility: CHU Angers
city: Annecy
country: France
facility: CH De La Region D Annecy
city: Besançon
country: France
facility: CHU-Hopital Jean Minjoz
city: Bron
country: France
facility: Hopital Cardio-Vasculaire Louise Pradel
city: Caen
country: France
facility: CHU Cote De Nacre
city: Clermont-Ferrand
country: France
facility: CHU - Hopital Gabriel Montpied
city: Créteil
country: France
facility: CHU Hopital Henri Mondor
city: Dijon
country: France
facility: CHU - Hopital Du Bocage
city: Grenoble
country: France
facility: CHU Hopital A. Michallon
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Clinique De La Sauvegarde
city: Marseille
country: France
facility: CHU Hopital La Timone
city: Metz
country: France
facility: Hopital Clinique Claude Bernard
city: Metz
country: France
facility: Hopital De Mercy
city: Montpellier
country: France
facility: CHU Hopital Arnaud De Villeneuve
city: Nancy
country: France
facility: CHU - Hopital Brabois
city: Nantes
country: France
facility: CHU - Hopital Guillaume et Rene Laenec
city: Nîmes
country: France
facility: Hopital Prive Les Franciscaines
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière, Vascular Surgery Department
city: Paris
country: France
facility: Groupe Hospitalier La Pitie Salpetriere
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: CHU - Hopital Haut Leveque
city: Reims
country: France
facility: CHU - Hopital Robert Debre
city: Rennes
country: France
facility: CHU - Hopital Pontchaillou
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Saint Denis
country: France
facility: Centre Cardiologique Du Nord
city: Saint-Denis
country: France
facility: CH Felix Guyon
city: Saint-Étienne
country: France
facility: CHU De Saint Etienne
city: Strasbourg
country: France
facility: Hopitaux Universitaires - Nouvel Hopital Civil
city: Toulouse
country: France
facility: Hôpital Rangueil, Cardiothoracic Surgery Department
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHU De Tours
city: Villeurbanne
country: France
facility: Clinique Du Tonkin - Medipole
Study officials:
affiliation: Centre Hospitalier Universitaire. Heart, Chest and Vascular Centre, AMIENS
name: Professor Thierry Caus
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.