N/A
Completed N=473
Cook IVC Filter Study
Source: ClinicalTrials.gov NCT02046096 ↗Enrolled (actual)
473
Serious AEs
25.2%
Results posted
Jan 2022
Primary outcomePrimary: The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling. — 317 Participants — p=<0.0001
Summary
This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling. |
317 | <0.0001 sig |
| PRIMARY The Rate of 12-month Freedom From Major Adverse Events (MAEs) |
81.5 | 0.369 |
| PRIMARY Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs). |
281 | 0.001 sig |
| SECONDARY Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling |
317; 147; 464 | — |
| SECONDARY Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata) |
281; 135; 416 | — |
| SECONDARY Number of Participants With Freedom From Grade 2 or Grade 3 Filter Leg Interaction With IVC, Filter Migration, Filter Fracture, and Filter Embolization at 12-month. |
274; 131; 405 | — |
Eligibility Criteria
Inclusion Criteria
- Requires temporary or permanent IVC filter placement for the prevention of PE
Exclusion Criteria
- Less than 18 years of age
- Known hypersensitivity or contraindication to contrast medium that cannot be adequately premedicated
- Known allergy or sensitivity to cobalt, chromium, or nickel
- Pregnant or planning to become pregnant in the next 12 months
- Patient refuses blood transfusions
- At risk of septic embolism
- Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
- Existing IVC filter
- Duplicate IVC
- Anatomy that would prevent safe filter placement (e.g., condition of access vessels)
- IVC diameter > 30 mm or < 15 mm
Data sourced from ClinicalTrials.gov (NCT02046096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.