Recurrent Pulmonary Embolism (Disorder)
Conditions
Brief summary
IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up
Detailed description
IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up
Interventions
DIAGNOSTIC_TESTIVUS
IVUS
Sponsors
Novate Medical Limited, a BTG Group Company
NC Heart and Vascular Research, LLC
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age * Signed the informed consent document * Participants from the SENTRY clinical trial willing to undergo one time IVUS evaluation ( outpatient )
Exclusion criteria
* Any filter that remained non converted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency of the inferior vena cava | 3-5 years | — |
| Cylindrical frame integrity | 3-5 years | Cylindrical frame integrity |
| Impact of the Sentry cylindrical frame on the vessel wall evaluation for endothelialization and neointimal hyperplasia and wall dynamics | 3-5 years | Impact of the Sentry cylindrical frame on the vessel wall evaluation for endothelialization and neointimal hyperplasia and wall dynamics |
| Presence and characterization of adherent thrombus | 3-5 years | Presence and characterization of adherent thrombus |
Countries
United States
Outcome results
None listed