A prospective study to evaluate the safety and performance of a shape memory polymer foam embolization device for arterial or venous embolization of the peripheral vasculature system.

A prospective study to evaluate the safety and performance of a shape memory polymer foam embolization device for arterial or venous embolization of the peripheral vasculature system by assessing rates of serious adverse events and unanticipated serious adverse device effects from the day of procedure through 30 days post-procedure.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000906358

Enrollment

Registered

2017-06-20

Start date

2017-08-01

Completion date

2019-05-06

Last updated

2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to evaluate the safety and performance of a shape memory polymer foam embolization device in subjects requiring arterial or venous embolization of the peripheral vasculature.

Interventions

The shape memory polymer foam embolization device is intended for use by physicians trained and experienced in embolization techniques, angiographic techniques, and interventional procedures. In this single arm study, each study subject will undergo a single index procedure for permanent device implantation by a qualified interventional radiolologist. The pushable polymeric embolization device is designed to be delivered to the target vessel using a guidewire through a standard catheter, guid

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Study Participant is greater than or equal to 18 years of age and less than or equal to 75 years of age; Study Participant is considered a candidate for arterial or venous embolization of the peripheral vasculature; Study Participant has a target vessel >2 mm and <9 mm in diameter, measured during angiographic imaging.

Exclusion criteria

Study Participant has an inability to provide written informed consent; Study Participant has inappropriate anatomy of the vasculature for the safe access and/or the deployment of the study device, Study Participant has known hypersensitivity or contraindication to nickel or nitinol; Study Participant has a condition that inhibits radiographic visualization during the implantation procedure; Study Participant has a history of allergy to contrast medium that cannot be managed medically; Study Participant has an uncontrolled co-morbid medical condition that would adversely affect participation in the Study; Study Participant is pregnant or a lactating female.

Outcome results