Pathology of the Thoracic AortaNCT05030740
French Assessment of the Relay Plus and Relay NBS Plus Thoracic Stent-Graft
An observational study of Pathology of the Thoracic Aorta and Aneurysm Thoracic, run by Vascutek Ltd. at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Pathology of the Thoracic Aorta, Aneurysm Thoracic, Pseudo-aneurysm, Thoracic
- How many people
- 170 participants
- Where
- 10 sitesFrance
- Study dates
- 18 Dec 2014to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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 join
- 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) .
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel - HCL
Bron, 69677
CHU de Créteil - Hôpital Henri Mondor
Créteil, 94010
Hôpital Edouard Herriot - HCL
Lyon, 69002
Hôpital Européen Georges Pompidou
Paris, 75908
CHU de Bordeaux - Hôpital Haut Lévêque
Pessac, 33604
CHU Rennes - Hôpital Pontchaillou
Rennes, 35033
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, 42055
Hôpitaux Universitaires de Strasbourg - NHC
Strasbourg, 67091
Clinique du Tonkin
Villeurbanne, 69626
About this study
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
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.
Read the 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
- 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)
- Keywords
- Aorta, thoracic, Aortic arch, Aorta, descending, Thoracic aortic aneurysm, Thoracic aortic dissection, Thoracic aortic stent, TAAA
- Medical subject headings
- Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term all-cause mortality
Measured: 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
Measured: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Rate of neurological complications
Measured: 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
Measured: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Rate of device-related complications
Measured: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Surgical conversion rate
Measured: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary procedure rate
Measured: Postoperatively, 1 year, 2 years, 3 years, 4 years, 5 years
Pathology-related mortality rate
Measured: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start18 Dec 2014
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathology of the Thoracic AortaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federation of Medical Specialties
- Responsible party
- Sponsor
- Investigators
- Pr. Pascal Desgranges, Principal investigator, Henri Mondor Hospital, Creteil, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030740
- Sponsor's protocol ID
- EFER
- Status last verified
- Feb 2025
- First submitted
- 18 Aug 2021
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05030740
- Acronym / sponsor ID
- EFER
- 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)
- Keywords
- Aorta, thoracic, Aortic arch, Aorta, descending, Thoracic aortic aneurysm, Thoracic aortic dissection, Thoracic aortic stent, TAAA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Federation of Medical Specialties
- Study start
- 18 Dec 2014 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term all-cause mortality
Time frame: Any death occurring between the surgery when the stent-graft is introduced through the arterial access and the last follow-up at 5 years
7 secondary outcomes
Rate of exclusion of the aneurysm, penetrating aortic ulcer, false channel or rupture site, with no endoleak of any type
Time frame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Rate of neurological complications
Time frame: 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
Time frame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Rate of device-related complications
Time frame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Surgical conversion rate
Time frame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary procedure rate
Time frame: Postoperatively, 1 year, 2 years, 3 years, 4 years, 5 years
Pathology-related mortality rate
Time frame: Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pr. Pascal Desgranges principal investigator
Henri Mondor Hospital, Creteil, France
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathology of the Thoracic Aorta and Aneurysm Thoracic, run by Vascutek Ltd. at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term all-cause mortality (time frame: Any death occurring between the surgery when the stent-graft is introduced through the arterial access and the last follow-up at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.