N/A
Completed N=129
The SENTRY Clinical Study
Source: ClinicalTrials.gov NCT01975090 ↗Enrolled (actual)
129
Serious AEs
34.9%
Results posted
Oct 2017
Primary outcomePrimary: Number of Subjects That Reported Clinical Success — 111 Participants
Summary
The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide temporary protection against pulmonary embolism (PE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects That Reported Clinical Success |
111 | — |
| SECONDARY Number of Participants With IVC Filter Related Complications |
0; 0; 0; 0; 0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- > 18 years of age
- fully informed subject who has executed an Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
- willing and able to comply with follow-up visit requirements
- requirement of transient PE protection of 2.0 mg/dL
- active systemic infection
- life expectancy 60 days
- pregnant or plans to become pregnant during study follow-up period
- participating in another investigational trial that has not reached its primary endpoint
- known hypercoaguable state
- inherited or acquired hemostatic disorder
- history or presence of a caval stent or filter
- inability to gain femoral or jugular access
- duplicated or left sided IVC
- renal vein thrombosis or IVC thrombosis extending to the renal veins
- jugular and femoral vein irregularity, stenosis or aneurysm that would interfere with successful device delivery
- spinal irregularity that may interfere with successful device delivery
- occlusive or free-floating thrombus in the IVC
- contrast allergy that cannot be adequately pre-medicated
Data sourced from ClinicalTrials.gov (NCT01975090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.