TY - JOUR
T1 - One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial
T2 - Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter
AU - SENTRY Trial Investigators
AU - Dake, Michael D.
AU - Murphy, Timothy P.
AU - Krämer, Albrecht H.
AU - Darcy, Michael D.
AU - Sewall, Luke E.
AU - Curi, Michael A.
AU - Johnson, Matthew S.
AU - Arena, Frank
AU - Swischuk, James L.
AU - Ansel, Gary M.
AU - Silver, Mitchell J.
AU - Saddekni, Souheil
AU - Brower, Jayson S.
AU - Mendes, Robert
AU - Dake, Michael D.
AU - Feezor, Robert
AU - Kalva, Sanjeeva
AU - Kies, Darren
AU - Bosiers, Marc
AU - Ziegler, Werner
AU - Farber, Mark
AU - Paolini, David
AU - Spillane, Robert
AU - Jones, Steven
AU - Peeters, Patrick
N1 - Funding Information: The study was funded by Novate Medical (Galway, Ireland). Writing support services were provided by Galen Press (Austerlitz, New York) and paid for by the study sponsor. The authors thank Diane Gargus for clinical trial management. Funding Information: The prospective, multicenter, nonrandomized, single-arm SENTRY Clinical Trial was conducted at 23 sites in the United States (n = 20), Belgium (n = 2), and Chile (n = 1). The protocol was approved by the appropriate Institutional Review Boards or Ethics Committees, and all study procedures were performed in accordance with the guidelines of good clinical practice and applicable regulations. Novate Medical was the sole sponsor of the study, which was conducted under an investigational device exemption (IDE G110111), in compliance with applicable provisions of 21 CFR Parts 50, 54, and 812 and in accordance with the ethical principles of the Declaration of Helsinki. The study was registered before the start of patient enrollment (ClinicalTrials.gov ID NCT01975090). Publisher Copyright: © 2018 SIR
PY - 2018/10
Y1 - 2018/10
N2 - Purpose: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods: At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months. Results: Clinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%–99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%–100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months. 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 12 months of imaging-intense follow-up.
AB - Purpose: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods: At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months. Results: Clinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%–99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%–100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months. 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 12 months of imaging-intense follow-up.
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U2 - 10.1016/j.jvir.2018.05.009
DO - 10.1016/j.jvir.2018.05.009
M3 - Article
C2 - 30177423
SN - 1051-0443
VL - 29
SP - 1350-1361.e4
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 10
ER -