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Device

Adient Absorbable Filter for Pulmonary Embolism

N/A

Waitlist Available

Led By Matthew Johnson, MD

Research Sponsored by Adient Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older

Be older than 18 years old

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks, 10 weeks, and 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating a new absorbable filter to help reduce the occurrence of potentially life-threatening pulmonary embolism in people with temporary risk factors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include local reactions at the implant site, issues related to filter placement such as incorrect positioning or movement over time, and rare chances of allergic reactions to materials in individuals with known sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is low or I need dialysis.

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The distance from my kidney vein to where my pelvic veins meet is less than 7cm.

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I have had radiation therapy in my abdomen or pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 10 weeks, and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks, 10 weeks, and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 10 weeks, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Composite Safety Endpoint - Prophylactic Cohort: incidence of absorbable filter deployment without complications

Primary Composite Safety and Effectiveness Endpoint - Therapeutic Cohort: composite rate of technical filter placement success without complications

Primary DVT Safety Endpoint - Prophylactic Cohort: incidence of all DVT post index event

+1 more

Secondary study objectives

Incidence of DVT

Incidence of common femoral and iliac venous thrombosis ipsilateral to filter insertion site

Incidence of major bleeding

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met