IMPEDE and IMPEDE-FX Embolization Plug Registry (EMBO-PMS)

Shape Memory Medical

Status: Enrolling

Conditions: Peripheral Vascular Embolization

Treatments: Device: IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill

Study type: Observational

Funder types: Industry

Identifiers

NCT04044443

CRD1012

Details and patient eligibility

About

EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Study participant is ≥18 years of age
• Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature

Exclusion criteria

• Study participant has an inability to provide written informed consent
• Study participant/treatment outside of the approved study device labeling, instructions for use (IFU)
• Study participant is a prisoner or member of other vulnerable population