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

NCT03735472 | Completed DMC

• 1 other identifier: EPI-Flex
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 37

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.

Conditions

Aortic Arch; Aneurysm, Dissecting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

Study Arms (1)

Aneurysm/Dissection

Thoraflex™ Hybrid

Device: Thoraflex™ Hybrid

Interventions

Thoraflex™ Hybrid DEVICE

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.

Aneurysm/Dissection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vascutek Ltd.: lead

Study Sites (37)

Centre Hospitalier University (University Hospital centre)

Amiens, France

Location

CHU Angers

Angers, France

Location

CH De La Region D Annecy

Annecy, France

Location

CHU-Hopital Jean Minjoz

Besançon, France

Location

Hopital Cardio-Vasculaire Louise Pradel

Bron, France

Location

CHU Cote De Nacre

Caen, France

Location

CHU - Hopital Gabriel Montpied

Clermont-Ferrand, France

Location

CHU Hopital Henri Mondor

Créteil, France

Location

CHU - Hopital Du Bocage

Dijon, France

Location

CHU Hopital A. Michallon

Grenoble, France

Location

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, France

Location

CHRU Lille

Lille, France

Location

Clinique De La Sauvegarde

Lyon, France

Location

CHU Hopital La Timone

Marseille, France

Location

Hopital Clinique Claude Bernard

Metz, France

Location

Hopital De Mercy

Metz, France

Location

CHU Hopital Arnaud De Villeneuve

Montpellier, France

Location

CHU - Hopital Brabois

Nancy, France

Location

CHU - Hopital Guillaume et Rene Laenec

Nantes, France

Location

Hopital Prive Les Franciscaines

Nîmes, France

Location

Groupe Hospitalier Pitié-Salpêtrière, Vascular Surgery Department

Paris, 75013, France

Location

Groupe Hospitalier La Pitie Salpetriere

Paris, France

Location

Hopital Bichat

Paris, France

Location

Hopital Europeen Georges Pompidou

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

CHU - Hopital Haut Leveque

Pessac, France

Location

CHU - Hopital Robert Debre

Reims, France

Location

CHU - Hopital Pontchaillou

Rennes, France

Location

CHU Charles Nicolle

Rouen, France

Location

Centre Cardiologique Du Nord

Saint-Denis, France

Location

CH Felix Guyon

Saint-Denis, France

Location

CHU De Saint Etienne

Saint-Etienne, France

Location

Hopitaux Universitaires - Nouvel Hopital Civil

Strasbourg, France

Location

Hôpital Rangueil, Cardiothoracic Surgery Department

Toulouse, 31009, France

Location

Clinique Pasteur

Toulouse, France

Location

CHU De Tours

Tours, France

Location

Clinique Du Tonkin - Medipole

Villeurbanne, France

Location

Related Publications (9)

• 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.

  PMID: 12354739 BACKGROUND

• 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.

  PMID: 11700491 BACKGROUND

• 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.

  PMID: 12830086 BACKGROUND

• 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.

  PMID: 11068215 BACKGROUND

• 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.

  PMID: 18406159 BACKGROUND

• 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.

  PMID: 22653445 BACKGROUND

• 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.

  PMID: 25133099 BACKGROUND

• 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.

  PMID: 19097813 BACKGROUND

• 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.

  PMID: 23977597 BACKGROUND

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Professor Thierry Caus

  Centre Hospitalier Universitaire. Heart, Chest and Vascular Centre, AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: November 8, 2018
• Study Start: April 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: November 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (37)