MANTA Registry for Vascular Large-bore Closure (MARVEL)

Essential Medical

Status: Completed

Conditions: Femoral Arteriotomy Closure

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03330002

PSD-212

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Per MANTA VCD Instructions for Use (IFU)

Trial design

500 participants in 1 patient group

CE-marked MANTA vascular closure devices per IFU

Description:

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

Treatment:

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