A Random Selection of Patients From the SENTRY Study Who Have a Bioconverted Sentry IVC Filter in Situ With a Minimum Dwell Time of 24 Months From a Single Center Follow up

Completed

• Conditions: Recurrent Pulmonary Embolism (Disorder)

• Registration Number: NCT04208139
• Lead Sponsor: NC Heart and Vascular Research, LLC

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

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Study Start: 2020-03-14
• Primary Completion: 2020-09-21
• Study Completion: 2020-10-01
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cylindrical frame integrity	3-5 years	Cylindrical frame integrity
Patency of the inferior vena cava	3-5 years
Presence and characterization of adherent thrombus	3-5 years	Presence and characterization of adherent thrombus
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

Trial Locations

Locations (1)

NC Heart and Vascular Research, LLC; 🇺🇸 Raleigh, North Carolina, United States