MANTA Registry for Vascular Large-bore Closure

Overview

The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.

Full Title of Study: “Post-Market Clinical Registry to Evaluate the Safety and Performance of MANTA Vascular Closure Device (VCD) Under Real World Conditions in the European Union (EU)”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 8, 2019

Interventions

  • Device: CE-marked MANTA vascular closure device (VCD)
    • Compile real word data on MANTA VCD.

Arms, Groups and Cohorts

  • CE-marked MANTA vascular closure devices per IFU
    • Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc.

Clinical Trial Outcome Measures

Primary Measures

  • Time to Hemostasis
    • Time Frame: Immediately after deployment of MANTA VCD
    • The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
  • Number of Participants With One or More Major Access Site Related Complications
    • Time Frame: within 30 days of procedure
    • Major access site related complications adapted from the VARC-2 definitions

Secondary Measures

  • Number of Participants With One or More Minor Access Site Related Complications
    • Time Frame: within 30 days of procedure
    • Minor access site related complications adapted from the VARC-2 definitions

Participating in This Clinical Trial

Per MANTA VCD Instructions for Use (IFU)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Essential Medical, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicolas Van Mieghem, MD, Principal Investigator, Erasmus Medical Center Rotterdam Netherlands

References

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.

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