Clinical trial NCT05030740: French Assessment of the Relay Plus and Relay NBS Plus Thoracic Stent-Graft
Official title: Thoracic Aortic Stent-graft Study for the Treatment of Thoracic Aortic Pathologies - Assessment of the Relay Plus and Relay NBS Plus Stent-graft
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Federation of Medical Specialties
First posted: 2021-09-01
Enrollment: 170
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Study outline:

French observational, prospective, multi-center, non-randomized, single arm and open-label study.

Study device:

RELAY PLUS and RELAY NBS PLUS thoracic aortic stent or future range extension models, excluding custom-made devices.

A total of 160 patients will be included in France consecutively from all participating centers and among users of the studied stent-graft (all of the centers) or any new center during the inclusion period. The patient will be considered as included in the study when the RELAY PLUS or RELAY NBS PLUS stent-graft is introduced via the surgical or percutaneous approach and provided that the patient meets all of the study eligibility criteria.

The primary endpoint of this study is the 5-year mortality rate (all causes). The objective will be to assess the interest of the technique in terms of the long-term efficacy and safety of the use of the RELAY PLUS or RELAY NBS PLUS stent-graft (i.e. at 5 years) on a cohort of patients representative of the population treated under actual conditions of use.

The implantation of the RELAY PLUS or RELAY NBS PLUS thoracic aortic stent-graft must be carried out in accordance with recommendations issued by the Haute Autorité de Santé (HAS) including:

* Carrying out the implantation in centers with expertise in both endovascular and surgical treatments, and with an adequate technical platform.
* The implementation of a multidisciplinary discussion, in particular on the risk of surgical conversion and the possible use of cardiopulmonary bypass (CPB).
* Verification of the presence of a proximal neck of at least 2 cm in length, allowing for the stent to be placed.
* The need to educate patients about the advantages and disadvantages of the repair techniques available, such as open surgery and endo-aortic stent (EAS).
* Annual monitoring by CT-scan with contrast, or MRI + x-ray.

As this study is observational, no specific examination or procedure outside the framework of the current practice of each center is required.

A summary report will be submitted annually to the Haute Autorité de Santé (HAS). The final report was submitted on 31July2024

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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) .

Primary outcomes:
measure: Long-term all-cause mortality
timeFrame: 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:
measure: Rate of exclusion of the aneurysm, penetrating aortic ulcer, false channel or rupture site, with no endoleak of any type
timeFrame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Rate of neurological complications
timeFrame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Rate of cardiac, renal and pulmonary complications
timeFrame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Rate of device-related complications
timeFrame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Surgical conversion rate
timeFrame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Secondary procedure rate
timeFrame: Postoperatively, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Pathology-related mortality rate
timeFrame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel - HCL
city: Créteil
country: France
facility: CHU de Créteil - Hôpital Henri Mondor
city: Lyon
country: France
facility: Hôpital Edouard Herriot - HCL
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital Haut Lévêque
city: Rennes
country: France
facility: CHU Rennes - Hôpital Pontchaillou
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
city: Saint-Étienne
country: France
facility: CHU Saint Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - NHC
city: Villeurbanne
country: France
facility: Clinique du Tonkin
Study officials:
affiliation: Henri Mondor Hospital, Creteil, France
name: Pr. Pascal Desgranges
role: PRINCIPAL_INVESTIGATOR
References: