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
Sponsor
NC Heart and Vascular Research, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT04208139
Collaborator
Novate Medical Limited, a BTG Group Company (Other)
11
1
6.6
1.7
Study Details
Study Description
Brief Summary
IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up
Study Design
Study Type:
Observational
Actual Enrollment
:
11 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
Actual Study Start Date
:
Mar 14, 2020
Actual Primary Completion Date
:
Sep 21, 2020
Actual Study Completion Date
:
Oct 1, 2020
Outcome Measures
Primary Outcome Measures
- Patency of the inferior vena cava [3-5 years]
- Cylindrical frame integrity [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 [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 [3-5 years]
Presence and characterization of adherent thrombus
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NC Heart and Vascular Research, LLC | Raleigh | North Carolina | United States | 27607 |
Sponsors and Collaborators
- NC Heart and Vascular Research, LLC
- Novate Medical Limited, a BTG Group Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
NC Heart and Vascular Research, LLC
ClinicalTrials.gov Identifier:
NCT04208139
Other Study ID Numbers:
- Version 1.0
First Posted:
Dec 23, 2019
Last Update Posted:
Apr 6, 2022
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms: