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Completed

NCT Number: NCT04208139

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

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

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Key information

Conditions

Recurrent Pulmonary Embolism (Disorder) Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVUS

Diagnostic Test

IVUS

Primary outcomes

  1. Patency of the inferior vena cava

    Time frame: 3-5 years

  2. Cylindrical frame integrity

    Time frame: 3-5 years

    Cylindrical frame integrity

  3. Impact of the Sentry cylindrical frame on the vessel wall evaluation for endothelialization and neointimal hyperplasia and wall dynamics

    Time frame: 3-5 years

    Impact of the Sentry cylindrical frame on the vessel wall evaluation for endothelialization and neointimal hyperplasia and wall dynamics

  4. Presence and characterization of adherent thrombus

    Time frame: 3-5 years

    Presence and characterization of adherent thrombus

Sponsors and collaborators

Lead sponsor

NC Heart and Vascular Research, LLC

Other

Collaborators

  • Novate Medical Limited, a BTG Group Company

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2019
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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