Clinical trial NCT03330002: MANTA Registry for Vascular Large-bore Closure
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Arteriotomy Closure
Keywords: Arterial Closure Device
Large Bore Closure Device
Lead sponsor: Essential Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.

Brief summary: 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.


Eligibility criteria: Per MANTA VCD Instructions for Use (IFU)

Primary outcomes:
measure: Time to Hemostasis
timeFrame: Immediately after deployment of MANTA VCD
measure: Number of Participants With One or More Major Access Site Related Complications
timeFrame: within 30 days of procedure
Secondary outcomes:
measure: Number of Participants With One or More Minor Access Site Related Complications
timeFrame: within 30 days of procedure
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
city: Vancouver
country: Canada
facility: Vancouver General Health
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Turku
country: Finland
facility: University of Turku
city: Amsterdam
country: Netherlands
facility: OLVG
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Erasmus Medical Center Rotterdam Netherlands
name: Nicolas Van Mieghem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.