Aortic Diseases Clinical Trial
Official title:
Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases
Verified date | January 2022 |
Source | Medtronic Cardiovascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this study is to assess the benefits of endovascular technique in terms of efficacy and safety of Valiant Thoracic Stent Graft with the Captivia Delivery System in the treatment of thoracic aortic disease, in a cohort of patients representative of the population treated under real-life conditions of use in France for up to 5 years.
Status | Completed |
Enrollment | 160 |
Est. completion date | December 9, 2021 |
Est. primary completion date | June 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Any patient requiring placement of the Valiant Thoracic Stent Graft for the treatment of a disease of his/her descending thoracic aorta. - Patient or holder of parental authority not opposed to the collection and release of the personal information required by the study. - Patient or holder of parental authority has consented for study participation and the Medtronic approved Data Release Form has been signed and personally dated by patient or holder of parental authority and by the investigator. Exclusion Criteria: - Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad). - Prior implantation of a thoracic stent graft. |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens Picardie, Hôpital Sud | Amiens | |
France | CHU de Bordeaux, Groupe Hospitalier Pellegrin | Bordeaux | |
France | Hôpital Henri Mondor | Créteil | |
France | CHU Grenoble, Hôpital A. Michallon | La Tronche | |
France | Hôpital Privé de Parly 2 | Le Chesnay | |
France | Centre Chirurgical Marie Lannelongue | Le Plessis-Robinson | |
France | CHU de Limoges | Limoges | |
France | Hôpital de la Timone | Marseille | |
France | Hôpital Nord | Marseille | |
France | Hôpital Privé Vert Coteau | Marseille | |
France | Hôpital Européen Georges Pompidou | Paris | |
France | Hôpital Pitié Salpêtrière | Paris | |
France | CHU de Saint-Etienne, Hôpital Nord | Saint Priest en Jarez | |
France | Clinique Belledonne | Saint-Martin-d'Hères | |
France | CHU Rangueil | Toulouse | |
France | Clinique Pasteur | Toulouse | |
France | Clinique du Tonkin | Villeurbanne |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiovascular |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality | 5 years | ||
Secondary | Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site | Through 5 years | ||
Secondary | Major Adverse Events | This includes respiratory, neurological, vascular, cardiac, renal, bleeding, visceral and infectious complications and any complication leading to death | Through 5 years | |
Secondary | Conversion to open repair | Through 5 years | ||
Secondary | Endovascular or surgical secondary procedures | Through 5 years | ||
Secondary | Adverse device effects | Through 5 years | ||
Secondary | Thoracic disease-related mortality | Through 5 years |
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