MANTA Registry for Vascular Large-bore Closure

Completed

• Conditions: Femoral Arteriotomy Closure
• Interventions: Device: CE-marked MANTA vascular closure device (VCD)

• Registration Number: NCT03330002
• Lead Sponsor: Essential Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Start: 2018-02-23
• Primary Completion: 2019-08-08
• Study Completion: 2021-02-01
• Results First Submitted: 2021-03-17
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-12
• Last Update Submitted: 2021-04-12
• Results First Posted: 2021-05-05
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Major Access Site Related Complications	within 30 days of procedure	Major access site related complications adapted from the VARC-2 definitions
Time to Hemostasis	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).

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

St Paul's Hospital; 🇨🇦 Vancouver, Canada

Vancouver General Health; 🇨🇦 Vancouver, Canada

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

OLVG; 🇳🇱 Amsterdam, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

University of Turku; 🇫🇮 Turku, Finland