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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208139
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
Novate Medical Limited, a BTG Group Company
Information provided by (Responsible Party):
NC Heart and Vascular Research, LLC

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

Condition or disease Intervention/treatment
Recurrent Pulmonary Embolism (Disorder) Diagnostic Test: IVUS

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

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Other
Time Perspective: Other
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
Estimated Study Start Date : March 30, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 30, 2020

Intervention Details:
  • Diagnostic Test: IVUS
    IVUS


Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with at least 24 months dwell time will undergo IVUS assessment of the inferior vena cava
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208139


Contacts
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Contact: Robert Mendes, MD 919-784-2300 robert.mendes@unchealth.unc.edu
Contact: Rebecca Palermo, MS 919-784-3795 rebecca.palermo@unchealth.unc.edu

Sponsors and Collaborators
NC Heart and Vascular Research, LLC
Novate Medical Limited, a BTG Group Company
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Responsible Party: NC Heart and Vascular Research, LLC
ClinicalTrials.gov Identifier: NCT04208139    
Other Study ID Numbers: Version 1.0
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases