NCT03330002

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
5 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 23, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 5, 2021

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

October 31, 2017

Results QC Date

March 17, 2021

Last Update Submit

April 12, 2021

Conditions

Femoral Arteriotomy Closure

Keywords

Arterial Closure DeviceLarge Bore Closure Device

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Number of Participants With One or More Minor Access Site Related Complications

    within 30 days of procedure

Study Arms (1)

CE-marked MANTA vascular closure devices per IFU

Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc.

Device: CE-marked MANTA vascular closure device (VCD)

Interventions

CE-marked MANTA vascular closure device (VCD)DEVICE

Compile real word data on MANTA VCD.

CE-marked MANTA vascular closure devices per IFU

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.

Per MANTA VCD Instructions for Use (IFU)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

St Paul's Hospital

Vancouver, Canada

Location

Vancouver General Health

Vancouver, Canada

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

University of Turku

Turku, Finland

Location

OLVG

Amsterdam, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Related 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.

    PMID: 25027520BACKGROUND

  • 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.

    PMID: 23026738BACKGROUND

Results Point of Contact

Title
Darra Bigelow, Clinical Trials Manager
Organization
Essential Medical, a wholly owned subsidiary of Teleflex, Inc.
darra.bigelow@teleflex.com
610-331-7299

Study Officials

  • Nicolas Van Mieghem, MD

    Erasmus Medical Center Rotterdam Netherlands

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 6, 2017

Study Start

February 23, 2018

Primary Completion

August 8, 2019

Study Completion

February 1, 2021

Last Updated

May 5, 2021

Results First Posted

May 5, 2021

Record last verified: 2021-04

Locations

CH(1)FI(2)DK(1)CA(2)NL(3)