The DENALI Trial: An Interim Analysis of a Prospective, Multicenter Study of the Denali Retrievable Inferior Vena Cava Filter

Abstract

In this interim report, the nitinol retrievable IVC filter provided protection against pulmonary embolism, and the device could be retrieved with a low rate of complications.

Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism

“…Through the 24-month follow-up, there were a total of 17 cases of CEC-confirmed new or worsening DVT in 14 patients (10.9%), which also compared favorably with recent findings for retrievable filters (16)(17)(18)(19)22). Only the 1 new symptomatic access-site DVT that occurred at 8 days was considered to be procedure related, whereas none was confirmed as being device related.…”

“…For the patients in the SENTRY trial-all of whom had documented DVT or PE or were at high risk of developing DVT or PE and had a contraindication to or failure of anticoagulation-freedom from new symptomatic PE was 100% through the first year of follow-up, an outcome comparing favorably with PE rates in recent trials of retrievable IVC filters (16)(17)(18)(19)22). Between 12 and 24 months, new symptomatic nonfatal PE was identified in 2 of 85 evaluable patients (2.4%), in each of whom the 6-month imaging had shown the study device to be bioconverted with the filter arms fully retracted to the IVC wall.…”

“…Study endpoints are specified and defined in Appendix B (available online on the article's Supplemental Material page at www.jvir.org). Study endpoints were formulated in accordance with Society of Interventional Radiology reporting standards (15) and American College of Radiology guidelines (13), with reference to recent IDE studies (16)(17)(18)(19) and the PRESERVE trial (NCT02381509), which was also designed in conjunction with the FDA, following FDA safety communications in 2010 and 2014 responding to the reported high rates of complications associated with prolonged indwelling of retrievable IVC filters and emphasizing the need for vigilant follow-up (20,21). Clinical assessment for potential PE-related symptoms was performed at each follow-up timepoint, and suspicion of PE was supported by appropriate imaging.…”

One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter

“…Study end points were formulated in accordance with SIR reporting standards (24) and ACR guidelines (3) and with reference to recent IDE studies (25)(26)(27)(28). The predefined primary end point was clinical success at 6 months, a composite of technical success (filter deployment as intended without acute events), freedom from symptomatic PE through 60 days, and 6-month freedom from filterrelated complications, including tilting, migration, embolization, fracture, perforation, symptomatic caval thrombosis, any other symptomatic filter-related complication requiring invasive intervention, or filter-related death.…”

Inferior Vena Cava Filters: Indications, Outcomes, and Evidence

“…The most recently published (2014) FDA-mandated clinical device trial described the results with the Denali Retrievable Vena Cava Filter (Bard Peripheral Vascular, Tempe, AZ) [22]. This prospective, multicenter, nonrandomized, single-arm study included 200 patients and 6 months of follow-up.…”