CompletedNo phase
French Assessment of the Relay Plus and Relay NBS Plus Thoracic Stent-Graft
Key facts
- Who runs it
- Vascutek Ltd.
- Where
- France10 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 170 people enrolled
- Started
- 18 Dec 2014
- Ended
- 15 Jan 2024
- Type of study
- Observational
- Record updated
- 19 February 2025
Who can take part
- Age
- Up to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- 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)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 19 February 2025