Pulmonary EmbolismNCT05127915
US Pivotal Clinical Study of the Adient Absorbable Filter for the Prevention of Pulmonary Embolism
A study testing Adient absorbable filter + best practice VTE prophylaxis and best practice VTE prophylaxis in people with Pulmonary Embolism, run by Adient Medical at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Adient absorbable filter + best practice VTE prophylaxis and best practice VTE prophylaxis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 854 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Willing to comply with the specified follow-up requirements including contrast enhanced CTs for the 9-month duration of the study
- For female subjects of childbearing potential: a negative pregnancy test within 48 hours prior to the implantation procedure
- For the prophylactic cohort, high risk VTE denoted by either:
- Caprini score > 8 for surgical ICU, Parvizi score ≥ 150 for TKA (total knee replacement), ISS score ≥ 24 for trauma.
- For the therapeutic cohort, documented VTE per the following:
Show all 9Show fewer
- Pulmonary thromboembolism when anticoagulants are contraindicated, Failure of anticoagulant therapy in thromboembolic diseases, Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
- Requirement of temporary PE protection (8 weeks) based on clinical judgment
- Fully informed subject or caretaker consent having executed an Institutional Review Board (IRB) or approved informed consent.
Who cannot join
- Expected high VTE risk to extend beyond 8 weeks.
- Vena cava filter currently implanted
- History of abdominal or pelvic radiation therapy
- Previous IVC filter placement/retrieval within 6 months prior to randomization
- Confirmed positive blood cultures within the last 48 hours if there is bacteremia
- Known sensitivity to radiographic contrast medium that cannot be adequately prophylactically pre-medicated
Show all 19Show fewer
- Known allergy or intolerance to IVC filter materials (i.e. PDSII absorbable suture)
- Pregnant, lactating, or plans to become pregnant during investigation follow-up period
- Renal insufficiency (GFR < 60) or requiring renal replacement therapy
- IVC effective diameter (D) <16 mm or >28 mm anywhere within L1-L4, D = √(APLat)
- Less than 7cm from inferior-most renal vein to the iliac vein confluence
- Duplication of the IVC
- Any thrombus or occlusion in IVC on pre-procedural CT cavogram
- Life expectancy of < 12 months
- Simultaneous participation in another investigative drug or device trial that has not reached its primary endpoint
- Other co-morbid condition that, in the opinion of the Investigator, could limit the subject's ability to participate in or would affect the scientific integrity of the study
- Previously enrolled in a clinical investigation of the Adient filter.
- For Roll In, patient has advanced heart failure or recent (6 weeks) myocardial infarction. - - -
- Advanced heart failure is defined by NYHA class IV or AHA/ACC/HFSA stage D or LVEF < 40%. Subjects with MI diagnosed with ECG alone without MI history and symptoms are not excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
IU Health University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: 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
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.
Read more
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
- Being tested
- Adient absorbable filter + best practice VTE prophylaxis, best practice VTE prophylaxis
- Keywords
- Vena Cava Filters, Embolic Protection Devices
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adient absorbable filter + best practice VTE prophylaxisDevice
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.
best practice VTE prophylaxisDevice
Best practice VTE prophylaxis includes sequential compression machines, compression stockings, and anticoagulants (blood thinners) when indicated.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic | Experimental | 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. Receives: Device: Adient absorbable filter + best practice VTE prophylaxis |
| Prophylactic - Test | Experimental | 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. Receives: Device: Adient absorbable filter + best practice VTE prophylaxis |
| Prophylactic - Control | Active comparator | 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. Receives: Device: best practice VTE prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint - Prophylactic Cohort: incidence of new clinically significant PE
Clinically significant PE includes asymptomatic proximal PE screened at 2 weeks, in addition to symptomatic PE through 8 weeks post index event confirmed by computed tomography (CT) angiography. Proximal PE includes thrombus (blood clots) observed in the pulmonary trunk, main pulmonary arteries, or lobar arteries.
Measured: 2 weeks for asymptomatic proximal PE screening and through 8 weeks for symptomatic PE
Primary Composite Safety Endpoint - Prophylactic Cohort: incidence of absorbable filter deployment without complications
Potential complications include: (a) caval thrombotic occlusion within 9 months, (b) all-filter embolization within 9 months, (c) serious filter-related complications within 9 months, (d) filter placement procedural related Series Adverse Events (SAE) within the perioperative period (96 hours), (e) filter placement vascular access site SAE within the perioperative period, (f) symptomatic PE subsequent to filter deployment within 9 months.
Measured: 96 hours to 9 months depending on the safety parameter
Primary DVT Safety Endpoint - Prophylactic Cohort: incidence of all DVT post index event
All DVT includes both symptomatic DVT and asymptomatic DVT screened at 2 weeks, 10 weeks and 9 months.
Measured: 9 months overall duration
Primary Composite Safety and Effectiveness Endpoint - Therapeutic Cohort: composite rate of technical filter placement success without complications
Potential complications include (a) new symptomatic PE through 8 weeks, (b) filter migration (> 2cm), (c) filter embolization, (d) caval perforation (> 5mm), (e) symptomatic caval thrombosis, and (f) any other symptomatic filter-related complication requiring invasive intervention, or filter related death.
Measured: 9 months
Secondary outcomes (8)
Incidence of new symptomatic PE through 8 weeks confirmed by CT angiography
Measured: 8 weeks
Miller Score for symptomatic and asymptomatic PE
Quantification of the occlusion of the pulmonary vascular bed from a PE.
Measured: 9 months
Incidence of caval occlusion / thrombosis confirmed by CT cavogram
Measured: 10 weeks
Incidence of IVC caval stenosis and occlusion confirmed by CT cavogram
Measured: 9 months
Incidence of common femoral and iliac venous thrombosis ipsilateral to filter insertion site
Detected on ultrasound.
Measured: 2 weeks, 10 weeks, and 9 months
Incidence of DVT
Detected on ultrasound.
Measured: 2 weeks, 10 weeks, and 9 months
Incidence of major procedure-related or device-related adverse events
Measured: 9 months
Incidence of major bleeding
Major bleeding defined by International Society on Thrombosis and Haemostases.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start27 Jan 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 854 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adient Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania, ICON plc
- Responsible party
- Sponsor
- Investigators
- Matthew Johnson, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127915
- Sponsor's protocol ID
- PROT-CI2021
- Status last verified
- Aug 2023
- First submitted
- 9 Nov 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Elizondo G, Eggers M, Falcon M, Trevino M, Marrufo R, Perez C, Nunez E, Moreno R, Mitchell A, Sheppard A, Dria S, Jay T, Kirk R, Hovsepian D, Steele J. First-in-Human Study with Eight Patients Using an Absorbable Vena Cava Filter for the Prevention of Pulmonary Embolism. J Vasc Interv Radiol. 2020 Nov;31(11):1817-1824. doi: 10.1016/j.jvir.2020.07.021. Epub 2020 Sep 29.
PubMed 33008719Eggers M, Rousselle S, Urtz M, Albright R, Will A, Jourden B, Godshalk C, Dria S, Huang S, Steele J. Randomized Controlled Study of an Absorbable Vena Cava Filter in a Porcine Model. J Vasc Interv Radiol. 2019 Sep;30(9):1487-1494.e4. doi: 10.1016/j.jvir.2019.03.010. Epub 2019 Jun 13.
PubMed 31202677Huang SY, Eggers M, McArthur MJ, Dixon KA, McWatters A, Dria S, Hill LR, Melancon MP, Steele JR, Wallace MJ. Safety and Efficacy of an Absorbable Filter in the Inferior Vena Cava to Prevent Pulmonary Embolism in Swine. Radiology. 2017 Dec;285(3):820-829. doi: 10.1148/radiol.2017161880. Epub 2017 Jul 14.
PubMed 28708470Dria SJ, Eggers MD. In vitro evaluation of clot capture efficiency of an absorbable vena cava filter. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):472-8. doi: 10.1016/j.jvsv.2016.05.006. Epub 2016 Jul 25.
PubMed 27639002Eggers MD, McArthur MJ, Figueira TA, Abdelsalam ME, Dixon KP, Pageon LR, Wallace MJ, Huang SY. Pilot in vivo study of an absorbable polydioxanone vena cava filter. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):409-420. doi: 10.1016/j.jvsv.2015.03.004. Epub 2015 Jun 18.
PubMed 26992619Eggers MD, Reitman CA. In vitro analysis of polymer candidates for the development of absorbable vascular filters. J Vasc Interv Radiol. 2012 Aug;23(8):1023-30. doi: 10.1016/j.jvir.2012.05.039.
PubMed 22840802
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05127915
- Acronym / sponsor ID
- PROT-CI2021
- Conditions
- Pulmonary Embolism
- Keywords
- Vena Cava Filters, Embolic Protection Devices
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 854 participants (estimated)
- Lead sponsor
- Adient MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Avania, ICON plc
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic | Experimental | Device: Adient absorbable filter + best practice VTE prophylaxisThe 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. |
| Prophylactic - Test | Experimental | Device: Adient absorbable filter + best practice VTE prophylaxisThe 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. |
| Prophylactic - Control | Active comparator | Device: best practice VTE prophylaxisThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 years or older
- Willing to comply with the specified follow-up requirements including contrast enhanced CTs for the 9-month duration of the study
- For female subjects of childbearing potential: a negative pregnancy test within 48 hours prior to the implantation procedure
- Caprini score > 8 for surgical ICU, Parvizi score ≥ 150 for TKA (total knee replacement), ISS score ≥ 24 for trauma.
- Pulmonary thromboembolism when anticoagulants are contraindicated, Failure of anticoagulant therapy in thromboembolic diseases, Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
Key exclusion criteria (19 listed)
- Expected high VTE risk to extend beyond 8 weeks.
- Vena cava filter currently implanted
- History of abdominal or pelvic radiation therapy
- Previous IVC filter placement/retrieval within 6 months prior to randomization
- Confirmed positive blood cultures within the last 48 hours if there is bacteremia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adient absorbable filter + best practice VTE prophylaxisAdient 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 | Prophylactic - Test, Therapeutic |
| best practice VTE prophylaxisBest practice VTE prophylaxis includes sequential compression machines, compression stockings, and anticoagulants (blood thinners) when indicated. | Device | Prophylactic - Control |
Primary outcome
Primary Effectiveness Endpoint - Prophylactic Cohort: incidence of new clinically significant PE
Time frame: 2 weeks for asymptomatic proximal PE screening and through 8 weeks for symptomatic PE
Clinically significant PE includes asymptomatic proximal PE screened at 2 weeks, in addition to symptomatic PE through 8 weeks post index event confirmed by computed tomography (CT) angiography. Proximal PE includes thrombus (blood clots) observed in the pulmonary trunk, main pulmonary arteries, or lobar arteries.
Primary Composite Safety Endpoint - Prophylactic Cohort: incidence of absorbable filter deployment without complications
Time frame: 96 hours to 9 months depending on the safety parameter
Potential complications include: (a) caval thrombotic occlusion within 9 months, (b) all-filter embolization within 9 months, (c) serious filter-related complications within 9 months, (d) filter placement procedural related Series Adverse Events (SAE) within the perioperative period (96 hours), (e) filter placement vascular access site SAE within the perioperative period, (f) symptomatic PE subsequent to filter deployment within 9 months.
Primary DVT Safety Endpoint - Prophylactic Cohort: incidence of all DVT post index event
Time frame: 9 months overall duration
All DVT includes both symptomatic DVT and asymptomatic DVT screened at 2 weeks, 10 weeks and 9 months.
Primary Composite Safety and Effectiveness Endpoint - Therapeutic Cohort: composite rate of technical filter placement success without complications
Time frame: 9 months
Potential complications include (a) new symptomatic PE through 8 weeks, (b) filter migration (> 2cm), (c) filter embolization, (d) caval perforation (> 5mm), (e) symptomatic caval thrombosis, and (f) any other symptomatic filter-related complication requiring invasive intervention, or filter related death.
8 secondary outcomes
Incidence of new symptomatic PE through 8 weeks confirmed by CT angiography
Time frame: 8 weeks
Miller Score for symptomatic and asymptomatic PE
Time frame: 9 months
Incidence of caval occlusion / thrombosis confirmed by CT cavogram
Time frame: 10 weeks
Incidence of IVC caval stenosis and occlusion confirmed by CT cavogram
Time frame: 9 months
Incidence of common femoral and iliac venous thrombosis ipsilateral to filter insertion site
Time frame: 2 weeks, 10 weeks, and 9 months
Incidence of DVT
Time frame: 2 weeks, 10 weeks, and 9 months
Incidence of major procedure-related or device-related adverse events
Time frame: 9 months
Incidence of major bleeding
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 33008719Elizondo G, Eggers M, Falcon M, Trevino M, Marrufo R, Perez C, Nunez E, Moreno R, Mitchell A, Sheppard A, Dria S, Jay T, Kirk R, Hovsepian D, Steele J. First-in-Human Study with Eight Patients Using an Absorbable Vena Cava Filter for the Prevention of Pulmonary Embolism. J Vasc Interv Radiol. 2020 Nov;31(11):1817-1824. doi: 10.1016/j.jvir.2020.07.021. Epub 2020 Sep 29.
- Background: PubMed 31202677Eggers M, Rousselle S, Urtz M, Albright R, Will A, Jourden B, Godshalk C, Dria S, Huang S, Steele J. Randomized Controlled Study of an Absorbable Vena Cava Filter in a Porcine Model. J Vasc Interv Radiol. 2019 Sep;30(9):1487-1494.e4. doi: 10.1016/j.jvir.2019.03.010. Epub 2019 Jun 13.
- Background: PubMed 28708470Huang SY, Eggers M, McArthur MJ, Dixon KA, McWatters A, Dria S, Hill LR, Melancon MP, Steele JR, Wallace MJ. Safety and Efficacy of an Absorbable Filter in the Inferior Vena Cava to Prevent Pulmonary Embolism in Swine. Radiology. 2017 Dec;285(3):820-829. doi: 10.1148/radiol.2017161880. Epub 2017 Jul 14.
- Background: PubMed 27639002Dria SJ, Eggers MD. In vitro evaluation of clot capture efficiency of an absorbable vena cava filter. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):472-8. doi: 10.1016/j.jvsv.2016.05.006. Epub 2016 Jul 25.
- Background: PubMed 26992619Eggers MD, McArthur MJ, Figueira TA, Abdelsalam ME, Dixon KP, Pageon LR, Wallace MJ, Huang SY. Pilot in vivo study of an absorbable polydioxanone vena cava filter. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):409-420. doi: 10.1016/j.jvsv.2015.03.004. Epub 2015 Jun 18.
- Background: PubMed 22840802Eggers MD, Reitman CA. In vitro analysis of polymer candidates for the development of absorbable vascular filters. J Vasc Interv Radiol. 2012 Aug;23(8):1023-30. doi: 10.1016/j.jvir.2012.05.039.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Johnson, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adient absorbable filter + best practice VTE prophylaxis and best practice VTE prophylaxis in people with Pulmonary Embolism, run by Adient Medical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint - Prophylactic Cohort: incidence of new clinically significant PE (time frame: 2 weeks for asymptomatic proximal PE screening and through 8 weeks for symptomatic PE). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127915, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.