Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta

Aortic Arch; Aneurysm, Dissecting Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03735472
• Other study ID #: EPI-Flex
• Status: Active, not recruiting
• Start date: April 2016
• Est. completion date: July 2022

Study information

• Verified date: May 2022
• Source: Vascutek Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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, endoleak and evolution of the aortic thoracic stent over time.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 404
• Est. completion date: July 2022
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Arch; Aneurysm, Dissecting

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	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 La Pitie Salpetriere	Paris
France	Groupe Hospitalier Pitié-Salpêtrière, Vascular Surgery Department	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	Centre Cardiologique Du Nord	Saint Denis
France	CH Felix Guyon	Saint-Denis
France	CHU De Saint Etienne	Saint-Étienne
France	Hopitaux Universitaires - Nouvel Hopital Civil	Strasbourg
France	Clinique Pasteur	Toulouse
France	Hôpital Rangueil, Cardiothoracic Surgery Department	Toulouse
France	CHU De Tours	Tours
France	Clinique Du Tonkin - Medipole	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Vascutek Ltd.

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View Citation

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 analy — View 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. — View Citation

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. — View Citation

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. Review. — View 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. Review. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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	Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Secondary	Death	Death linked to the device, to the procedure, all causes	Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Secondary	Transitory paraplegia/Para-paresis	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.
Secondary	Follow-up surgery	Follow-up Surgery linked/not 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.
Secondary	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	Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.
Secondary	Rates of visceral malperfusion, neurological, renal, cardiac, respiratory and Haemorrhagic complications	Rates of visceral malperfusion, neurological, renal, cardiac, respiratory and Haemorrhagic complications	Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.