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.

Not Applicable

Completed

• Conditions: arterial or venous condition requiring embolization; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12617000906358
• Lead Sponsor: Shape Memory Medical Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-20
• Study Completion: 2019-06-19
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events reported by site will be reviewed by medical monitor to assess primary endpoint of freedom from incidence of serious adverse events and unanticipated serious adverse device effects.[30 days post-procedure.]

Secondary Outcome Measures

Name	Time	Method
Technical success defined as embolization of the target vessel after deployment of the study device.[Post-procedure]