MANTA Registry for Vascular Large-bore Closure

Femoral Arteriotomy Closure Clinical Trial

— MARVEL  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330002
• Other study ID #: PSD-212
• Status: Completed
• Start date: February 23, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2021
• Source: Essential Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 1, 2021
• Est. primary completion date: August 8, 2019
• Gender: All
• Age group: 18 Years and older
• Eligibility: Per MANTA VCD Instructions for Use (IFU)

Related Conditions & MeSH terms

• Femoral Arteriotomy Closure

Intervention

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

Locations

Country	Name	City	State
Canada	St Paul's Hospital	Vancouver
Canada	Vancouver General Health	Vancouver
Denmark	Aarhus University Hospital	Aarhus
Finland	Helsinki University Hospital	Helsinki
Finland	University of Turku	Turku
Netherlands	OLVG	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Erasmus Medical Center	Rotterdam
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Essential Medical, Inc.

Countries where clinical trial is conducted

Canada,  Denmark,  Finland,  Netherlands,  Switzerland, 

References & Publications (2)

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. — View Citation

Kappetein AP, Head SJ, Généreux 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, Rodés-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Hemostasis	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).	Immediately after deployment of MANTA VCD
Primary	Number of Participants With One or More Major Access Site Related Complications	Major access site related complications adapted from the VARC-2 definitions	within 30 days of procedure
Secondary	Number of Participants With One or More Minor Access Site Related Complications	Minor access site related complications adapted from the VARC-2 definitions	within 30 days of procedure