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

Sponsor

Vascutek Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05030740

Collaborator

Federation of Medical Specialties (Other)

170

Enrollment

Locations

120

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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).

Study Design

Study Type:

Observational

Actual Enrollment :

170 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 18, 2014

Anticipated Primary Completion Date :

Dec 18, 2023

Anticipated Study Completion Date :

Dec 18, 2024

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Secondary procedure rate [Postoperatively, 1 year, 2 years, 3 years, 4 years, 5 years]
Pathology-related mortality rate [Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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) .

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel - HCL	Bron	France	69677
2	CHU de Créteil - Hôpital Henri Mondor	Créteil	France	94010
3	Hôpital Edouard Herriot - HCL	Lyon	France	69002
4	Hôpital Européen Georges Pompidou	Paris	France	75908
5	CHU de Bordeaux - Hôpital Haut Lévêque	Pessac	France	33604
6	CHU Rennes - Hôpital Pontchaillou	Rennes	France	35033
7	CHU de Rouen - Hôpital Charles Nicolle	Rouen	France	76031
8	CHU Saint Etienne - Hôpital Nord	Saint-Étienne	France	42055
9	Hôpitaux Universitaires de Strasbourg - NHC	Strasbourg	France	67091
10	Clinique du Tonkin	Villeurbanne	France	69626