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

Investigators, Sentry Trial

doi:10.1016/j.jvir.2018.05.009

Cited by 28 publications

(22 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Outcomes through 1 year of follow-up in the SENTRY clinical trial, which have been previously presented (12), are summarized in Appendix C (available online on the article's Supplemental Material page at www.jvir.org). Figure 2 shows the bioconversion status for all patients with imaging assessment at 6, 12, and 24 months.…”

Section: Resultsmentioning

confidence: 99%

“…The SENTRY clinical trial design was previously reported (12). This prospective, multicenter, nonrandomized, singlearm trial was conducted at 23 sites in the United States (n ¼ 20), Belgium (n ¼ 2), and Chile (n ¼ 1).…”

Section: Methodsmentioning

confidence: 99%

“…Study patient disposition through 24 months is detailed in Figure 1. Baseline characteristics of the patient population, previously described (12), are summarized in Table 1. The patient indications for filter placement, the reasons for inability to use anticoagulation therapy, and key procedural details are summarized in Table 2, along with the primary 6-month composite endpoint results.…”

Section: Study Device Procedures Patient Characteristics and Dispomentioning

confidence: 99%

“…Other symptomatic complications requiring invasive intervention adjudicated as being related to the procedure (12). Of the cases of new symptomatic DVT, 3 were recorded during the second year of follow-up-at days 395, 411, and 624 (discussed above)-in patients who had been symptomatic at baseline with known DVT or PE.…”

Section: Vte Outcomes Through 24 Monthsmentioning

confidence: 99%

“…The bioconversion of the Sentry device obviates the need for a separate secondary device-removal procedure. In the prospective multicenter SENTRY clinical trial, interim 1-year outcomes with the Sentry device included clinical success for 97.4% of evaluable patients (95% confidence interval [CI], 92.5%-99.1%); technical success in 129 of 130 attempted filter deployments; no new cases of symptomatic PE through 1 year of follow-up; no filter-related imaging complications; a 1.6% rate of filter-related symptomatic complications; and successful filter bioconversion for 96.4% (106/110) of patients (12). Reported here are final results from the SENTRY clinical trial through completed 24month clinical follow-up.…”

mentioning

confidence: 99%

See 4 more Smart Citations

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

Dake

Murphy

Krämer

et al. 2020

Journal of Vascular and Interventional Radiology

Self Cite

View full text Add to dashboard Cite

Purpose: To report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods:In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years. Results:The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n ¼ 126) through 1 year and 2.4% (n ¼ 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filterrelated deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms. Conclusions:The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Study Device Procedures Patient Characteristics and Dispomentioning

confidence: 99%

Section: Vte Outcomes Through 24 Monthsmentioning

confidence: 99%

mentioning

confidence: 99%

See 3 more Smart Citations