Adient Absorbable Filter for Pulmonary Embolism

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMatthew Johnson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Adient Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

This trial is for adults who need temporary protection from pulmonary embolism (PE) but can't use blood thinners due to conditions like major trauma or upcoming surgery. It's also for those with a high risk of developing clots in their legs that could travel to the lungs, as indicated by specific scoring systems used by doctors.

Inclusion Criteria

I need short-term protection from pulmonary embolism as advised by my doctor.

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

I am 18 years old or older.

See 4 more

Exclusion Criteria

I have advanced heart failure or had a heart attack in the last 6 weeks.

My kidney function is low or I need dialysis.

You have a filter inside a large vein called the vena cava.

See 15 more

Treatment Details

Interventions

Adient Absorbable Filter (Device)

Trial OverviewThe study tests an Adient absorbable filter designed to prevent PE by catching leg clots before they reach the lungs. Unlike metal filters, it dissolves after about 6-8 months, eliminating the need for surgical removal and potentially reducing complications associated with long-term implants.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: TherapeuticExperimental Treatment1 Intervention

The therapeutic arm will include subjects with diagnosed symptomatic VTE (PE and/or DVT). Each subject will receive an Adient absorbable filter to help prevent a subsequent PE. All study subjects will return to the investigation site for the Follow-up Visits at Week 2 (±3 days), Week 10 (±1 week) and Month 9 (±2 weeks). Subjects will be interviewed and examined at each follow-up visit to perform safety and filter status evaluations.

Group II: Prophylactic - TestExperimental Treatment1 Intervention

The Prophylactic - Test arm will include subjects who are at transient high risk for PE and do not have diagnosed symptomatic VTE (PE and/or DVT). If randomized into this prophylactic arm, study subjects will receive an Adient absorbable filter to help prevent PE in addition to being administered current best practice PE prevention, namely sequential compression machines, compression stockings, and anticoagulants when indicated. All study subjects will return to the investigation site for the Follow-up Visits at Week 2 (±3 days), Week 10 (±1 week) and Month 9 (±2 weeks). Subjects will be interviewed and examined at each follow-up visit to perform safety and filter status evaluations.

Group III: Prophylactic - ControlActive Control1 Intervention

The Prophylactic - Control arm will include subjects who are at transient high risk for PE and do not have diagnosed symptomatic VTE (PE and/or DVT). If randomized into this prophylactic arm, study subjects will receive current best practice PE prevention, namely sequential compression machines, compression stockings, and anticoagulants when indicated. All study subjects will return to the investigation site for the Follow-up Visits at Week 2 (±3 days), Week 10 (±1 week) and Month 9 (±2 weeks). Subjects will be interviewed and examined at each follow-up visit.