US Pivotal Clinical Study of the Adient Absorbable Filter for the Prevention of Pulmonary Embolism
- Conditions
- Pulmonary Embolism
- Interventions
- Device: Adient absorbable filter + best practice VTE prophylaxisDevice: best practice VTE prophylaxis
- Registration Number
- NCT05127915
- Lead Sponsor
- Adient Medical
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 854
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Therapeutic Adient absorbable filter + best practice VTE prophylaxis 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. Prophylactic - Control best practice VTE prophylaxis 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. Prophylactic - Test Adient absorbable filter + best practice VTE prophylaxis 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.
- Primary Outcome Measures
Name Time Method Primary Effectiveness Endpoint - Prophylactic Cohort: incidence of new clinically significant PE 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 DVT Safety Endpoint - Prophylactic Cohort: incidence of all DVT post index event 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 Endpoint - Prophylactic Cohort: incidence of absorbable filter deployment without complications 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 Composite Safety and Effectiveness Endpoint - Therapeutic Cohort: composite rate of technical filter placement success without complications 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.
- Secondary Outcome Measures
Name Time Method Miller Score for symptomatic and asymptomatic PE 9 months Quantification of the occlusion of the pulmonary vascular bed from a PE.
Incidence of common femoral and iliac venous thrombosis ipsilateral to filter insertion site 2 weeks, 10 weeks, and 9 months Detected on ultrasound.
Incidence of new symptomatic PE through 8 weeks confirmed by CT angiography 8 weeks Incidence of IVC caval stenosis and occlusion confirmed by CT cavogram 9 months Incidence of major bleeding 9 months Major bleeding defined by International Society on Thrombosis and Haemostases.
Incidence of caval occlusion / thrombosis confirmed by CT cavogram 10 weeks Incidence of DVT 2 weeks, 10 weeks, and 9 months Detected on ultrasound.
Incidence of major procedure-related or device-related adverse events 9 months
Trial Locations
- Locations (2)
IU Health University Hospital
🇺🇸Indianapolis, Indiana, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States