Aortic Arch; Aneurysm, DissectingNCT03735472
Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta
An observational study of Aortic Arch; Aneurysm, Dissecting, run by Vascutek Ltd. at 37 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Arch; Aneurysm, Dissecting
- What is being tested?
- Thoraflex™ Hybrid
- Type of treatment
- Medical device
- How many people
- 351 participants
- Where
- 37 sitesFrance
- Study dates
- Apr 2016to Nov 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
France37 sites
Centre Hospitalier University (University Hospital centre)
Amiens
CHU Angers
Angers
CH De La Region D Annecy
Annecy
CHU-Hopital Jean Minjoz
Besançon
Hopital Cardio-Vasculaire Louise Pradel
Bron
CHU Cote De Nacre
Caen
CHU - Hopital Gabriel Montpied
Clermont-Ferrand
CHU Hopital Henri Mondor
Créteil
CHU - Hopital Du Bocage
Dijon
CHU Hopital A. Michallon
Grenoble
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson
CHRU Lille
Lille
Clinique De La Sauvegarde
Lyon
CHU Hopital La Timone
Marseille
Hopital Clinique Claude Bernard
Metz
Hopital De Mercy
Metz
CHU Hopital Arnaud De Villeneuve
Montpellier
CHU - Hopital Brabois
Nancy
CHU - Hopital Guillaume et Rene Laenec
Nantes
Hopital Prive Les Franciscaines
Nîmes
Groupe Hospitalier Pitié-Salpêtrière, Vascular Surgery Department
Paris, 75013
Groupe Hospitalier La Pitie Salpetriere
Paris
Hopital Bichat
Paris
Hopital Europeen Georges Pompidou
Paris
Institut Mutualiste Montsouris
Paris
CHU - Hopital Haut Leveque
Pessac
CHU - Hopital Robert Debre
Reims
CHU - Hopital Pontchaillou
Rennes
CHU Charles Nicolle
Rouen
Centre Cardiologique Du Nord
Saint-Denis
CH Felix Guyon
Saint-Denis
CHU De Saint Etienne
Saint-Etienne
Hopitaux Universitaires - Nouvel Hopital Civil
Strasbourg
Hôpital Rangueil, Cardiothoracic Surgery Department
Toulouse, 31009
Clinique Pasteur
Toulouse
CHU De Tours
Tours
Clinique Du Tonkin - Medipole
Villeurbanne
About this study
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
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.
Read the 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.
- Conditions
- Aortic Arch; Aneurysm, Dissecting
- Being tested
- Thoraflex™ Hybrid
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoraflex™ HybridDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aneurysm/Dissection | Thoraflex™ Hybrid Receives: Device: Thoraflex™ Hybrid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post-operative
Secondary outcomes (6)
Technical success
is defined as the placement and deployment of the a Vascutek Thoraflex™ Hybrid Device in the absence of mortality, conversion to conventional open surgical repair, failed patency, evidence of an unanticipated distal type I or type III endoleak on pre-discharge CT scan
Measured: Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Death
Death linked to the device, to the procedure, all causes
Measured: 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
Transitory paraplegia/Para-paresis
Measured: 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
Follow-up Surgery linked/not linked to the device
Measured: 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
No plication, torsion, occlusion and thrombosis of the device, Leak-tightness of the polyester prosthesis, Change over time of the thoracic stent graft
Measured: Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Rates of visceral malperfusion, neurological, renal, cardiac, respiratory and Haemorrhagic complications
Rates of visceral malperfusion, neurological, renal, cardiac, respiratory and Haemorrhagic complications
Measured: Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study startApr 2016
- Primary completionMay 2019
- Study completionNov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Aortic Arch; Aneurysm, DissectingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor Thierry Caus, Principal investigator, Centre Hospitalier Universitaire. Heart, Chest and Vascular Centre, AMIENS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735472
- Sponsor's protocol ID
- EPI-Flex
- Status last verified
- Nov 2024
- First submitted
- 16 Dec 2015
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 11700491Karck 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.
PubMed 12830086Usui 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.
PubMed 11068215Karck 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.
PubMed 18406159Shrestha 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.
PubMed 22653445Patel 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.
PubMed 25133099Tsai 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.
PubMed 19097813Jakob 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.
PubMed 23977597Bortone 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.
PubMed 12354739