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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 10 weeks, and 9 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Incidence of DVT
Incidence of IVC caval stenosis and occlusion confirmed by CT cavogram
Incidence of caval occlusion / thrombosis confirmed by CT cavogram
+5 moreTrial 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.
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Who is running the clinical trial?
AvaniaIndustry Sponsor
46 Previous Clinical Trials
8,044 Total Patients Enrolled
Adient MedicalLead Sponsor
ICON plcIndustry Sponsor
81 Previous Clinical Trials
24,360 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I need short-term protection from pulmonary embolism as advised by my doctor.The distance from my kidney vein to where my pelvic veins meet is less than 7cm.You have an allergy or intolerance to the materials used in the IVC filter, such as PDSII absorbable suture.You have had positive blood cultures for bacteria in the last 48 hours.You are at high risk of developing blood clots for a period longer than 8 weeks.You have participated in a study involving the Adient filter before.I am 18 years old or older.You have an extra vein in your body called the IVC.You have a high risk of blood clots based on specific scoring systems used for surgical and trauma patients.I have had radiation therapy in my abdomen or pelvis.The diameter of your vena cava (a large vein) in your lower back is not within the range of 16 to 28 millimeters.You are expected to live for less than a year.I have a blood clot issue that standard blood thinners haven't helped.You have a blood clot blocking the main vein leading to the heart, as seen on a CT scan before the procedure.You are allergic to the dye used in certain medical imaging tests, and pre-medications cannot prevent your allergic reaction.You had a filter put in or taken out of a large vein in your body within the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Prophylactic - Control
- Group 2: Therapeutic
- Group 3: Prophylactic - Test
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities available for individuals to become part of this clinical experiment?
"According to clinicaltrials.gov, this medical trial is not currently recruiting participants. It was posted on January 27th 2023 and last updated August 29th 2023; however, there are 79 other trials actively enrolling patients at the present moment."
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