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

Recurrent Pulmonary Embolism (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208139
• Other study ID #: Version 1.0
• Status: Completed
• Start date: March 14, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2019
• Source: NC Heart and Vascular Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up

Description:

IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 1, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Recurrent Pulmonary Embolism (Disorder)

Intervention

Diagnostic Test:
• IVUS
IVUS

Locations

Country	Name	City	State
United States	NC Heart and Vascular Research, LLC	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
NC Heart and Vascular Research, LLC	Novate Medical Limited, a BTG Group Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of the inferior vena cava		3-5 years
Primary	Cylindrical frame integrity	Cylindrical frame integrity	3-5 years
Primary	Impact of the Sentry cylindrical frame on the vessel wall evaluation for endothelialization and neointimal hyperplasia and wall dynamics	Impact of the Sentry cylindrical frame on the vessel wall evaluation for endothelialization and neointimal hyperplasia and wall dynamics	3-5 years
Primary	Presence and characterization of adherent thrombus	Presence and characterization of adherent thrombus	3-5 years