Recurrent Pulmonary Embolism (Disorder)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
An observational study of Recurrent Pulmonary Embolism (Disorder), run by NC Heart and Vascular Research, LLC at 1 site in United States.
Trial summary
IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Pulmonary Embolism (Disorder)
- What is being tested?
- IVUS
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2020to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with at least 24 months dwell time will undergo IVUS assessment of the inferior vena cava
Who may be able to join
- 18 years of age
- Signed the informed consent document
- Participants from the SENTRY clinical trial willing to undergo one time IVUS evaluation ( outpatient )
Who cannot join
- Any filter that remained non converted.
Trial locations and contacts
1 site in 1 country.
United States1 site
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607
About this study
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
IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up
Read the detailed description
IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up
- Conditions
- Recurrent Pulmonary Embolism (Disorder)
- Being tested
- IVUS
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUSDiagnostic test
IVUS
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency of the inferior vena cava
Measured: 3-5 years
Cylindrical frame integrity
Cylindrical frame integrity
Measured: 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
Measured: 3-5 years
Presence and characterization of adherent thrombus
Presence and characterization of adherent thrombus
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start14 Mar 2020
- Primary completion21 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pulmonary Embolism (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- NC Heart and Vascular Research, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Novate Medical Limited, a BTG Group Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208139
- Sponsor's protocol ID
- Version 1.0
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04208139
- Acronym / sponsor ID
- Version 1.0
- Conditions
- Recurrent Pulmonary Embolism (Disorder)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- NC Heart and Vascular Research, LLCUniversity, hospital or other
- Collaborators
- Novate Medical Limited, a BTG Group Company
- Study start
- 14 Mar 2020 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with at least 24 months dwell time will undergo IVUS assessment of the inferior vena cava
Key inclusion criteria (3 listed)
- 18 years of age
- Signed the informed consent document
- Participants from the SENTRY clinical trial willing to undergo one time IVUS evaluation ( outpatient )
Key exclusion criteria (1 listed)
- Any filter that remained non converted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUSIVUS | Diagnostic test | – |
Primary outcome
Patency of the inferior vena cava
Time frame: 3-5 years
Cylindrical frame integrity
Time frame: 3-5 years
Cylindrical frame integrity
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
Presence and characterization of adherent thrombus
Time frame: 3-5 years
Presence and characterization of adherent thrombus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pulmonary Embolism (Disorder), run by NC Heart and Vascular Research, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency of the inferior vena cava (time frame: 3-5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.