NCT05127915

US Pivotal Clinical Study of the Adient Absorbable Filter for the Prevention of Pulmonary Embolism

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 854 (estimated)
• Sponsor: Adient Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	Adient absorbable filter + best practice VTE prophylaxis	Adient absorbable filter helps prevent PE during an 8 week protection period then gradually breaks down into carbon dioxide and water within 6 to 8 months. The absorbable filter does not require removal.
DEVICE	best practice VTE prophylaxis	Best practice VTE prophylaxis includes sequential compression machines, compression stockings, and anticoagulants (blood thinners) when indicated.

Timeline

• Start date: 2023-01-27
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2021-11-19
• Last updated: 2023-08-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study