Adient Absorbable Filter for Pulmonary Embolism

Not currently recruiting at 1 trial location

Overseen By Mitchell Eggers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Adient Medical

Disqualifiers: Renal insufficiency, Pregnancy, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new absorbable filter, the Adient Absorbable Filter, designed to prevent pulmonary embolism (PE), a dangerous condition where blood clots travel to the lungs. The filter targets individuals temporarily unable to use blood thinners, often due to recent major injuries or upcoming surgeries. Unlike traditional filters that require removal, this one safely breaks down in the body after completing its function. Participants who might be suitable include those at high risk for blood clots from surgery, trauma, or other medical conditions that make standard blood thinners unsafe. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to safer alternatives for preventing pulmonary embolism.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that the absorbable filter is used in addition to current best practices, which include anticoagulants when indicated. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Adient absorbable filter is safe for preventing pulmonary embolism?

Research has shown that the Adient absorbable filter is safe for people. In a previous study, all 11 filters used did not cause major problems such as blood clots in the main vein that carries blood from the lower body to the heart, narrowing of this vein, or the filter pushing into the vein wall. There were also no reports of blood clots in the lungs, issues at the insertion site, or death. Another study with eight patients found the filter worked well in all cases, demonstrating success without serious side effects.

The filter is designed to break down into harmless substances after completing its function, reducing the risk of complications associated with traditional metal filters. This is because it is made from a type of suture material that has been safely used for over 40 years. Overall, these early findings suggest that the Adient absorbable filter is well-tolerated and safe for people at high risk for blood clots in the lungs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Adient absorbable filter is unique because it offers a new approach to preventing pulmonary embolism (PE) by being an absorbable device rather than a permanent one. Traditional treatments for PE prevention typically involve anticoagulants, which help thin the blood, or mechanical measures like compression stockings and compression machines. What sets the Adient filter apart is its ability to be absorbed by the body over time, potentially reducing long-term complications or the need for removal procedures. Researchers are excited about this treatment because it could provide a safer and more convenient option for patients who are at high risk of PE, offering both preventive and therapeutic benefits.

What evidence suggests that the Adient absorbable filter is effective for preventing pulmonary embolism?

Research has shown that the Adient absorbable filter effectively prevents pulmonary embolism (PE), a condition where blood clots block blood vessels in the lungs. One study demonstrated that the filter successfully prevented PE in all patients tested. It catches blood clots like traditional filters but dissolves over time, reducing the risk of complications. In this trial, participants in the therapeutic arm will receive the Adient absorbable filter to help prevent subsequent PE. Meanwhile, those in the Prophylactic - Test arm will receive the filter in addition to current best practice PE prevention methods. Early studies have also shown that these absorbable filters can safely capture clots and break down in the body. This new method might be a safer choice for patients who cannot take traditional blood-thinning medications. ^{1 2 3 4 6}

Who Is on the Research Team?

Matthew Johnson, MD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

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

You have a high risk of blood clots based on specific scoring systems used for surgical and trauma patients.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Adient absorbable filter for the prevention of pulmonary embolism

8 weeks

1 visit (in-person) for filter placement

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

3 visits (in-person) at Week 2, Week 10, and Month 9

Filter Resorption

The absorbable filter resorbs into carbon dioxide and water

6 to 8 months

What Are the Treatments Tested in This Trial?

Interventions

• Adient Absorbable Filter

Trial Overview The 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.

How Is the Trial Designed?

Group I: Therapeutic Experimental Treatment 1 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 - Test Experimental Treatment 1 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 - Control Active Control 1 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.

Who Is Running the Clinical Trial?

Adient Medical

Lead Sponsor

Trials

1

Recruited

850+

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33008719/

First-in-Human Study with Eight Patients Using an ... Conclusions: Implantation of an absorbable vena cava filter in a limited number of human subjects resulted in 100% clinical success. One planned ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05127915/us-pivotal-clinical-study-of-the-adient-absorbable-filter-for-the-prevention-of-pulmonary-embolism

US Pivotal Clinical Study of the Adient Absorbable Filter for ... The objective of the study is to evaluate the safety and efficacy of the Adient absorbable filter for the prevention of pulmonary embolism ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X2030634X

A review of preclinical absorbable inferior vena cava filters Absorbable IVCFs were effective in clot capturing and self-resorption and could decrease complications associated with standard IVCFs.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5708283/

Safety and Efficacy of an Absorbable Filter in the Inferior Vena ... The device is effective for the prevention of pulmonary embolism for at least 5 weeks after placement in swine.

5. jvsvenous.org jvsvenous.org/article/S2213-333X(16)30082-8/pdf

vitro evaluation of clot capture efficiency of an absorbable ... Objective: The purpose of this study was to determine the in vitro clot capture efficiency (CCE) of an investigational absorbable inferior vena cava filter ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/08850666231163141

Prophylactic Inferior Vena Cava Filters for Venous ... Conclusion: In trauma patients, moderate risk reduction of PE and fatal PE was demonstrated among observational data but not RCTs. The desirable ...