NCT04208139

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 14, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 6, 2022

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

December 3, 2019

Last Update Submit

April 5, 2022

Conditions

Recurrent Pulmonary Embolism (Disorder)

Outcome Measures

Primary Outcomes (4)

  • Patency of the inferior vena cava

    3-5 years

  • Cylindrical frame integrity

    Cylindrical frame integrity

    3-5 years

  • 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

  • Presence and characterization of adherent thrombus

    Presence and characterization of adherent thrombus

    3-5 years

Interventions

IVUSDIAGNOSTIC_TEST

IVUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with at least 24 months dwell time will undergo IVUS assessment of the inferior vena cava

You may qualify if:

  • years of age
  • Signed the informed consent document
  • Participants from the SENTRY clinical trial willing to undergo one time IVUS evaluation ( outpatient )

You may not qualify if:

  • Any filter that remained non converted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 23, 2019

Study Start

March 14, 2020

Primary Completion

September 21, 2020

Study Completion

October 1, 2020

Last Updated

April 6, 2022

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)