French Assessment of the Relay Plus and Relay NBS Plus Thoracic Stent-Graft

NCT05030740 | Completed

• 1 other identifier: EFER
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 10

Brief Summary

Stent treatment of thoracic aortic pathologies, including aneurysms, pseudo-aneurysms, dissections, intramural hematomas, penetrating ulcers and ruptures of the isthmus, seems to provide a likely benefit compared to surgery in terms of surgical mortality and severe morbidity. However, the data concerning the long-term fate of these stents are insufficient. For this reason, the French National Health Authority (HAS) requests a 5-year follow-up in relation to the renewal of insurance reimbursement for these stent-grafts. Therefore, this long-term observational study has been set up.

Conditions

Pathology of the Thoracic Aorta; Aneurysm Thoracic; Pseudo-aneurysm, Thoracic; Dissection of Thoracic Aorta; Intramural Haematoma of Thoracic Aorta; Penetrating Ulcer of Aorta (Disorder); Rupture of the Isthmus

Keywords

Aorta, thoracic; Aortic arch; Aorta, descending; Thoracic aortic aneurysm; Thoracic aortic dissection; Thoracic aortic stent; TAAA

Outcome Measures

Primary Outcomes (1)

• Long-term all-cause mortality

  Any death occurring between the surgery when the stent-graft is introduced through the arterial access and the last follow-up at 5 years

Secondary Outcomes (7)

• Rate of exclusion of the aneurysm, penetrating aortic ulcer, false channel or rupture site, with no endoleak of any type

  Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years

• Rate of neurological complications

  Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years

• Rate of cardiac, renal and pulmonary complications

  Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years

• Rate of device-related complications

  Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years

• Surgical conversion rate

  Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

160 eligible patients presenting a pathology of their descending thoracic aorta and having an indication for endovascular treatment of this pathology by the RELAY PLUS or RELAY NBS PLUS thoracic aortic stent-graft will be included consecutively in this observational study. The eligibility criteria will be limited in order to best represent the population treated under real conditions of use. The consecutive recruitment will be carried out in all the centers using the studied stent-graft.

You may qualify if:

• Patient requiring the placement of the RELAY PLUS or RELAY NBS PLUS thoracic aortic stent-graft for the treatment of a pathology of their descending thoracic aorta.
• Patient (or legal representative for minor patients) who does not object (in writing or verbally) to the collection and transmission of their data.

You may not qualify if:

• Patients for whom clinical follow-up is not possible, i.e. patients who are unable to return for follow-up visits (for example patients living abroad).
• Patient who earlier benefited from one or more thoracic stent-grafts and for whom a specific follow-up of the RELAY PLUS or RELAY NBS PLUS stent-graft would not be possible depending on the nature of their treatment (e.g. patient already treated with stent-graft in the descending and/or thoraco-abdominal aorta with several extensions) .

Sponsors & Collaborators

• Vascutek Ltd.: lead
• Federation of Medical Specialties: collaborator

Study Sites (10)

Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel - HCL

Bron, 69677, France

Location

CHU de Créteil - Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital Edouard Herriot - HCL

Lyon, 69002, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

CHU de Bordeaux - Hôpital Haut Lévêque

Pessac, 33604, France

Location

CHU Rennes - Hôpital Pontchaillou

Rennes, 35033, France

Location

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, 42055, France

Location

Hôpitaux Universitaires de Strasbourg - NHC

Strasbourg, 67091, France

Location

Clinique du Tonkin

Villeurbanne, 69626, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Pr. Pascal Desgranges

  Henri Mondor Hospital, Creteil, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: September 1, 2021
• Study Start: December 18, 2014
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

FR (10)