Valiant Evo International Clinical Trial

• Research type

  Research Study

• Full title

  Valiant Evo International Clinical Trial

• IRAS ID

  191634

• Contact name

  Colin Bicknell

• Contact email

  colin.bicknell@imperial.ac.uk

• Sponsor organisation

  Medtronic Bakken Research Center BV

• Clinicaltrials.gov Identifier

  NCT02625324

• Duration of Study in the UK

  2 years, 1 months, 30 days

• Research summary

  The Valiant Evo International Clinical Trial is a non-randomized, multicenter, open-label, prospective, single-arm trial. The trial is designed to assess the clinical safety and effectiveness of the Valiant Evo Thoracic Stent Graft System. A sample of 47 subjects will be included and evaluated for the 30-day primary endpoint. Data from these 47 subjects will be analyzed and used to support CE Mark approval. All subjects included will continue to be followed under this investigational protocol beyond the 30-day primary endpoint out to 12 months post-implantation. Subjects will have required follow-up evaluations at the following time points:
  1-month following the index procedure
  12-months following the index procedure
  All subjects will be consented for up to 2 years of follow-up. This is to accommodate any global clinical investigational requirements, if required.

  The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair. The Valiant Evo International Clinical Trial is a first-in human experience with the objective to provide clinical data for supporting CE marking via case series and descriptive statistics.
  Data collected during this trial may also be used in conjunction with data collected during a concurrently enrolling IDE trial to support commercial approval of the Valiant Evo Thoracic Stent Graft System in the United States.

  Lay Summary of Results

  A brief overview of the Valiant Evo International Clinical Trial can be found on clinicaltrials.gov with the following link: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkFuqhJeri3QAOnjZsgqsb7aLDfLgKVdxHlAl-2FJnsrFbRJLfXxObJt-2BwgfTWwpsNog970yYJK3yiFIjhcq75jvfk-3D1M9r_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81eF-2B9YNe-2BaxnF3dRWCh3EidvvNmb1cCu2WVHN1HlFmJBTwbs-2FErqGyCz5qqnTsyXKAB6Zv1uHwQb-2F3O0qgDofUK-2Ft7t6yRysD7PRK-2FY3BvHU1BBwZqVEIjhhWswINY-2F5wSb75dNUC5xyakr227MEcV6zLU6Jf2Q53Jz3-2F6FeWPklA-3D-3D&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7Ce80783deabe94345801608dc3f5fd9a2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638454928110511862%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=lcXKVlyHg2ShK6QsXEc104CH0tUNdjg1fwvCoSBv6PU%3D&reserved=0

  Clinical data were collected for the 100 patients enrolled in the Valiant Evo study. Patients were followed initially for a one year period that was extended to 5 years of follow up. An issue was found with the device, and the device was removed from the market in 2021. The patients enrolled in the trial were followed up to the 5 year time period and continue to follow up with their doctor following their completion of the clinical trial.
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkFuqhJeri3QAOnjZsgqsb7aLDfLgKVdxHlAl-2FJnsrFbRJLfXxObJt-2BwgfTWwpsNogzTbT1RA8whcRB9O-2BOONaABgVJ6Mk3p9w3dYqPX0RQeVSItO_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81eF-2B9YNe-2BaxnF3dRWCh3EideIcXeRHQ4nmCJgTmAqCDyz3lgyEMcU4AwU9HaWwS7cEUnpgzrZxR-2BBJRcSnlR7ecUQX8c4GPLlh658ZNxm3OCXwukxmSS-2FogI8PYx5KAziKAk7lvUiHOnyevc9M4jU4-2BOp229Y6chjKqFUuJxWDy-2Bw-3D-3D&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7Ce80783deabe94345801608dc3f5fd9a2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638454928110519310%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=AytrzEnKkJmfFGDj%2FqCXwA%2BaY9K8Ytk3yBumG4S%2F19U%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: The results of the study are publicly available on clinicaltrials.gov and can be accessed via the following link: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkFuqhJeri3QAOnjZsgqsb7aLDfLgKVdxHlAl-2FJnsrFbRJLfXxObJt-2BwgfTWwpsNogzTbT1RA8whcRB9O-2BOONaAAog8Ms7cBmR7e8kSsvIOyEepA3_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81eF-2B9YNe-2BaxnF3dRWCh3EidoEtAr8U6HS90tL1ZbGC6MCKP8bus0MRKcYJfyz5JfDebb6neEyjrMZqPrBoZSSagw50yLGaXNA3f0iW4VVBidQql4Dv6imBz-2FraI9HscglZeUxL922Pqi7GOd0Zz-2BEwwapIjZ76HI1VovP5tY8fEhQ-3D-3D&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7Ce80783deabe94345801608dc3f5fd9a2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638454928110525480%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=1Yo65isBFlu8C6l5EY7X5B9FOvdrs9RrJW62lHz5Ff4%3D&reserved=0

  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: The patient informed consent form contains a link to clinicaltrials.gov where patients can find trial results publicly available.
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: Study data is publicly available on clinicaltrials.gov. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkFuqhJeri3QAOnjZsgqsb7aLDfLgKVdxHlAl-2FJnsrFbRJLfXxObJt-2BwgfTWwpsNogzTbT1RA8whcRB9O-2BOONaABgVJ6Mk3p9w3dYqPX0RQeVwI3G_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81eF-2B9YNe-2BaxnF3dRWCh3EidGI-2BpVSfygsaq1nDzvyR-2Bfti-2BAYSGEMahRb-2FHrc82gwYGHgUh2n7sa6eOvxYbXB4M-2Bj1uTi9L6AT1QL4hWTwVIlMLfyiZ3t5JUn705EdU9ALqOCLZIzRRpQZlo9LW0OqkU1mgmGewbFGWeNlj2uySTw-3D-3D&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7Ce80783deabe94345801608dc3f5fd9a2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638454928110530701%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ijOyMJj4CTVPFVxGc4vGbObTzojwKCCFj1g3693vN6Q%3D&reserved=0
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: No tissue samples have been collected for this study.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  16/LO/0118

• Date of REC Opinion

  24 Mar 2016

• REC opinion

  Further Information Favourable Opinion