Study Results
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View full resultsBasic Information
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COMPLETED
500 participants
OBSERVATIONAL
2018-02-23
2021-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CE-marked MANTA vascular closure devices per IFU
Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc.
CE-marked MANTA vascular closure device (VCD)
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Interventions
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CE-marked MANTA vascular closure device (VCD)
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Essential Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nicolas Van Mieghem, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center Rotterdam Netherlands
Locations
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St Paul's Hospital
Vancouver, , Canada
Vancouver General Health
Vancouver, , Canada
Aarhus University Hospital
Aarhus, , Denmark
Helsinki University Hospital
Helsinki, , Finland
University of Turku
Turku, , Finland
OLVG
Amsterdam, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Luzerner Kantonsspital
Lucerne, , Switzerland
Countries
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References
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Kadakia MB, Herrmann HC, Desai ND, Fox Z, Ogbara J, Anwaruddin S, Jagasia D, Bavaria JE, Szeto WY, Vallabhajosyula P, Li R, Menon R, Kobrin DM, Giri J. Factors associated with vascular complications in patients undergoing balloon-expandable transfemoral transcatheter aortic valve replacement via open versus percutaneous approaches. Circ Cardiovasc Interv. 2014 Aug;7(4):570-6. doi: 10.1161/CIRCINTERVENTIONS.113.001030. Epub 2014 Jul 15.
Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PSD-212
Identifier Type: -
Identifier Source: org_study_id
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