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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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05030740
Study type Observational
Source Vascutek Ltd.
Contact
Status Active, not recruiting
Phase
Start date December 18, 2014
Completion date December 18, 2024

See also
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Recruiting NCT03322033 - Feasibility of Endovascular Repair of Ascending Aortic Pathologies N/A