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

Aneurysm Thoracic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05030740
• Other study ID #: EFER
• Status: Active, not recruiting
• Start date: December 18, 2014
• Est. completion date: December 18, 2024

Study information

• Verified date: August 2021
• Source: Vascutek Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: December 18, 2024
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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) .

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Thoracic
• Aneurysm, Dissecting
• Aortic Aneurysm, Thoracic
• Dissection of Thoracic Aorta
• Hematoma
• Rupture

Locations

Country	Name	City	State
France	Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel - HCL	Bron
France	CHU de Créteil - Hôpital Henri Mondor	Créteil
France	Hôpital Edouard Herriot - HCL	Lyon
France	Hôpital Européen Georges Pompidou	Paris
France	CHU de Bordeaux - Hôpital Haut Lévêque	Pessac
France	CHU Rennes - Hôpital Pontchaillou	Rennes
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen
France	CHU Saint Etienne - Hôpital Nord	Saint-Étienne
France	Hôpitaux Universitaires de Strasbourg - NHC	Strasbourg
France	Clinique du Tonkin	Villeurbanne

Sponsors (2)

Lead Sponsor	Collaborator
Vascutek Ltd.	Federation of Medical Specialties

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of neurological complications		Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	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
Secondary	Rate of device-related complications		Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Surgical conversion rate		Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Secondary procedure rate		Postoperatively, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Pathology-related mortality rate		Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years