Dedicated plug based closure for large bore access -The MARVEL prospective registry.

ABSTRACT:

Objectives

To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.

Background

The MANTA is a novel plug-based device for large bore arteriotomy closure.

Methods

We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent cli

SUBMITTER: Kroon HG 

PROVIDER: S-EPMC8246962 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature