Clinical trial NCT05127915: US Pivotal Clinical Study of the Adient Absorbable Filter for the Prevention of Pulmonary Embolism
Official title: A Prospective, Multicenter, Pivotal Study With Randomized Controlled Prophylactic and Independent Therapeutic Cohorts to Evaluate the Safety and Efficacy of an Absorbable Vena Cava Filter for Pulmonary Embolism Prevention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Vena Cava Filters
Embolic Protection Devices
Lead sponsor: Adient Medical
Sponsor class: INDUSTRY
Collaborators: name: Avania
name: ICON plc
First posted: 2021-11-19
Enrollment: 854
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to evaluate the safety and efficacy of the Adient absorbable filter for the prevention of pulmonary embolism (PE: blood clot in the lungs). PE claims the lives of over 100,000 Americans each year, more than breast cancer, traffic fatalities and HIV combined.

Pharmaceutical anticoagulation (blood thinners) that reduce blood clot formation represent the standard of care for treating patients at risk for PE. However, for people who are temporarily unable to use anticoagulants, such as those who have suffered major trauma or those who are scheduled for surgical procedures, inferior vena cava (IVC) filters are used to help protect against PE. These blood filters prevent large blood clots that originate in the deep veins of the legs (deep vein thrombosis (DVT)) from reaching your lungs causing a potentially life-threatening PE.

Conventional metal IVC filters have been proven effective at reducing the incidence of PE, however, most require retrieval. If not retrieved within a timely manner (months), they can perforate the IVC, impale nearby organs with their barbed struts, and cause blood clots.

In contrast, the Adient absorbable filter traps blood clots similar to conventional metal IVC filters, but following the 8 week protection period, the filter itself breaks down into carbon dioxide and water. Hence no filter retrieval is required and complications are less likely due to the shortened indwell time. Once blood clots are trapped in the absorbable filter, the body's thrombolytic enzymes dissolve the clots within weeks while the filter itself resorbs in 6 to 8 months. The absorbable filter is braided from absorbable suture that has been proven safe over 4 decades.

The question being addressed with the randomized controlled trial portion is whether the placement of the absorbable filter in addition to current best practice PE prevention (sequential compression machines, compression stockings, and anticoagulants when indicated) significantly reduces the incidence of clinically significant PE in high risk subjects.

The absorbable filter will be indicated for the temporary prevention of PE in patients with transient high risk for venous thromboembolism (DVT and/or PE) with or without venous thromboembolic disease and as an enhancement to pharmaceutical anticoagulation and mechanical prophylaxis.


Eligibility criteria: INCLUSION CRITERIA:

Aged 18 years or older

Willing to comply with the specified follow-up requirements including contrast enhanced CTs for the 9-month duration of the study

For female subjects of childbearing potential: a negative pregnancy test within 48 hours prior to the implantation procedure

For the prophylactic cohort, high risk VTE denoted by either:

Caprini score \> 8 for surgical ICU, Parvizi score ≥ 150 for TKA (total knee replacement), ISS score ≥ 24 for trauma.

For the therapeutic cohort, documented VTE per the following:

Pulmonary thromboembolism when anticoagulants are contraindicated, Failure of anticoagulant therapy in thromboembolic diseases, Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.

Requirement of temporary PE protection (8 weeks) based on clinical judgment

Fully informed subject or caretaker consent having executed an Institutional Review Board (IRB) or approved informed consent.

EXCLUSION CRITERIA:

Expected high VTE risk to extend beyond 8 weeks.

Vena cava filter currently implanted

History of abdominal or pelvic radiation therapy

Previous IVC filter placement/retrieval within 6 months prior to randomization

Confirmed positive blood cultures within the last 48 hours if there is bacteremia

Known sensitivity to radiographic contrast medium that cannot be adequately prophylactically pre-medicated

Known allergy or intolerance to IVC filter materials (i.e. PDSII absorbable suture)

Pregnant, lactating, or plans to become pregnant during investigation follow-up period

Renal insufficiency (GFR \< 60) or requiring renal replacement therapy

IVC effective diameter (D) \<16 mm or \>28 mm anywhere within L1-L4, D = √(AP\*Lat)

Less than 7cm from inferior-most renal vein to the iliac vein confluence

Duplication of the IVC

Any thrombus or occlusion in IVC on pre-procedural CT cavogram

Life expectancy of \< 12 months

Simultaneous participation in another investigative drug or device trial that has not reached its primary endpoint

Other co-morbid condition that, in the opinion of the Investigator, could limit the subject's ability to participate in or would affect the scientific integrity of the study

Previously enrolled in a clinical investigation of the Adient filter.

For Roll In, patient has advanced heart failure or recent (6 weeks) myocardial infarction. - - -

Advanced heart failure is defined by NYHA class IV or AHA/ACC/HFSA stage D or LVEF \< 40%. Subjects with MI diagnosed with ECG alone without MI history and symptoms are not excluded.

Primary outcomes:
measure: Primary Effectiveness Endpoint - Prophylactic Cohort: incidence of new clinically significant PE
timeFrame: 2 weeks for asymptomatic proximal PE screening and through 8 weeks for symptomatic PE
measure: Primary Composite Safety Endpoint - Prophylactic Cohort: incidence of absorbable filter deployment without complications
timeFrame: 96 hours to 9 months depending on the safety parameter
measure: Primary DVT Safety Endpoint - Prophylactic Cohort: incidence of all DVT post index event
timeFrame: 9 months overall duration
measure: Primary Composite Safety and Effectiveness Endpoint - Therapeutic Cohort: composite rate of technical filter placement success without complications
timeFrame: 9 months
Secondary outcomes:
measure: Incidence of new symptomatic PE through 8 weeks confirmed by CT angiography
timeFrame: 8 weeks
measure: Miller Score for symptomatic and asymptomatic PE
timeFrame: 9 months
measure: Incidence of caval occlusion / thrombosis confirmed by CT cavogram
timeFrame: 10 weeks
measure: Incidence of IVC caval stenosis and occlusion confirmed by CT cavogram
timeFrame: 9 months
measure: Incidence of common femoral and iliac venous thrombosis ipsilateral to filter insertion site
timeFrame: 2 weeks, 10 weeks, and 9 months
measure: Incidence of DVT
timeFrame: 2 weeks, 10 weeks, and 9 months
measure: Incidence of major procedure-related or device-related adverse events
timeFrame: 9 months
measure: Incidence of major bleeding
timeFrame: 9 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Matthew Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elizondo G, Eggers M, Falcon M, Trevino M, Marrufo R, Perez C, Nunez E, Moreno R, Mitchell A, Sheppard A, Dria S, Jay T, Kirk R, Hovsepian D, Steele J. First-in-Human Study with Eight Patients Using an Absorbable Vena Cava Filter for the Prevention of Pulmonary Embolism. J Vasc Interv Radiol. 2020 Nov;31(11):1817-1824. doi: 10.1016/j.jvir.2020.07.021. Epub 2020 Sep 29.
citation: Eggers M, Rousselle S, Urtz M, Albright R, Will A, Jourden B, Godshalk C, Dria S, Huang S, Steele J. Randomized Controlled Study of an Absorbable Vena Cava Filter in a Porcine Model. J Vasc Interv Radiol. 2019 Sep;30(9):1487-1494.e4. doi: 10.1016/j.jvir.2019.03.010. Epub 2019 Jun 13.
citation: Huang SY, Eggers M, McArthur MJ, Dixon KA, McWatters A, Dria S, Hill LR, Melancon MP, Steele JR, Wallace MJ. Safety and Efficacy of an Absorbable Filter in the Inferior Vena Cava to Prevent Pulmonary Embolism in Swine. Radiology. 2017 Dec;285(3):820-829. doi: 10.1148/radiol.2017161880. Epub 2017 Jul 14.
citation: Dria SJ, Eggers MD. In vitro evaluation of clot capture efficiency of an absorbable vena cava filter. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):472-8. doi: 10.1016/j.jvsv.2016.05.006. Epub 2016 Jul 25.
citation: Eggers MD, McArthur MJ, Figueira TA, Abdelsalam ME, Dixon KP, Pageon LR, Wallace MJ, Huang SY. Pilot in vivo study of an absorbable polydioxanone vena cava filter. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):409-420. doi: 10.1016/j.jvsv.2015.03.004. Epub 2015 Jun 18.
citation: Eggers MD, Reitman CA. In vitro analysis of polymer candidates for the development of absorbable vascular filters. J Vasc Interv Radiol. 2012 Aug;23(8):1023-30. doi: 10.1016/j.jvir.2012.05.039.