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The RETRIEVE trial: safety and effectiveness of the retrievable crux vena cava filter
H Bob Smouse1, Robert Mendes, Marc Bosiers
1Department of Vascular and Interventional Radiology, OSF St. Francis Medical Center, 530 NE Glen Oak, Peoria IL 61637, USA. bsmouse@cirarad.com
Insights
The Crux vena cava filter demonstrated safety and effectiveness in preventing pulmonary embolism (PE). This clinical trial showed high success rates for deployment, retrieval, and overall patient outcomes.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Pulmonary embolism (PE) poses a significant risk to patient health.
- Inferior vena cava (IVC) filters are used to prevent PE in high-risk patients.
- Evaluating new IVC filter devices is crucial for improving patient safety and treatment efficacy.
Purpose of the Study:
- To assess the safety and effectiveness of the Crux vena cava filter.
- To determine the clinical success rate of the Crux filter in patients at risk for PE.
- To evaluate device-related adverse events and retrieval success.
Main Methods:
- Prospective, international, multicenter, single-arm clinical trial.
- 125 patients implanted with the Crux filter.
- 180-day follow-up post-placement and 30-day post-retrieval.
Main Results:
- Clinical success rate of 96.0% (120/125 patients).
- High technical success (98.4%) and retrieval success (98.1%).
- Low rates of definite PE (2.4%) and no device migration or fracture observed.
Conclusions:
- The Crux vena cava filter is safe and effective for PE prevention.
- Achieved high clinical, technical, and retrieval success rates.
- Demonstrated a favorable safety profile in a large patient cohort.
Purpose:
To evaluate the safety and effectiveness of the Crux vena cava filter in patients at risk for pulmonary embolism (PE).
Materials And Methods:
The Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System trial was an international prospective, multicenter, single-arm clinical trial in 125 patients implanted with the Crux filter between June 2010 and June 2011. Follow-up was 180 days after filter placement and 30 days after filter retrieval. The primary objective was to determine whether the clinical success rate was at least 80%. Clinical success was defined as technical success of deployment and freedom from definite PE, filter migration, and device-related adverse events requiring intervention.
Results:
The clinical success rate was 96.0% (120 of 125), with a one-sided lower limit of the 95% confidence interval of 91.8%. The rate of technical success was 98.4% (123 of 125). There were three cases of definite PE (2.4%), two cases of deployment failure, and no cases of device migration, embolization, fracture, or tilting. Investigators observed nine cases of thrombus (all nonocclusive) in or near the filter (six during retrieval evaluation vena cavography, two during computed tomography [CT] scans for PE symptoms, and one during CT for cancer management) and 13 cases of deep vein thrombosis. Device retrieval was attempted at a mean of 84.6 days±57.6 (range, 6-190 d) after implantation and was successful for 98.1% of patients (53 of 54). All deaths (n = 14) were determined to be unrelated to the filter or PE.
Conclusions:
The Crux vena cava filter performed safely, with high rates of clinical, technical, and retrieval success.
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