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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS130005 / PSS001 |
| Date Original Plan Accepted |
01/23/2014
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| Date Current Plan Accepted |
01/23/2014
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| Study Name |
Celect IVC Filter
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| Device Name |
Vena Cava Filter
|
| Root Document Number |
K121057
K121629
K073374
K061815
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Study suspended pending submission of the final IDE report.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
473 enrolled patients: 324 patients in the Celect stratum and 149 patients in the Günther Tulip stratum
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| Actual Number of Sites Enrolled |
28 study sites in the U.S., U.K., and Australia
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| Patient Followup Rate |
80.4% (78/97) of eligible patients were seen for 12-month follow-up 94.9% (318/335) of patients had their filters retrieved during the study
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| Final Safety Findings |
The primary safety hypothesis was the rate of 12-month freedom from MAEs in the Celect stratum. Among patients in the Celect stratum, the following MAEs were reported through 12 months: clinical perforation (defined as protrusion of the filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ; documented using CT) for 23 patients (7.1%, n=324), new symptomatic DVT while the filter was indwelling for 17 patients (5.2%, n=324), IVC thrombotic occlusion for 2 patients (0.62%, n=324), and clinical migration (defined as caudal or cranial movement of a filter resulting in surgical or endovascular intervention) for 1 patient (0.31%, n=324). When analyzed according to the study protocol, the Kaplan Meier estimate for the rate of 12-month freedom from MAEs was 81.5% ± 4.5% (95% CI: 72.6%, 90.4%), which exceeded but was not statistically greater than the PG of 80% (p=0.369). The high rate of censoring, associated largely with the high rate of filter retrieval over time (n=204 Celect filters were retrieved before 12 months), caused the 12-month estimate to be considered less precise than planned. Therefore, a supplementary analysis was completed using a one-tailed exact binomial test. This analysis demonstrated the rate of 12-month freedom from MAEs to be 86.7% (281/324; 95% CI: 82.5%, 90.2%), which was statistically greater (p < 0.001) than the PG of 80%.
Two secondary endpoints were specific to safety outcomes. The first was the rate of 12- month freedom from MAEs; the rate for the Celect stratum was 86.7% (281/324), therate for the Günther Tulip stratum was 90.6% (135/149), and the rate for the combined patient population was 87.9% (416/473). The second was the rate of 12-month freedom from Grade 2 or Grade 3 filter leg interaction with the IVC, filter migration, filter fracture, and filter embolization; the rate for the Celect stratum was 84.6% (274/324), the rate for the Günther Tulip stratum was 87.9% (131/149), and the rate for the combined patient population was 85.6% (405/473).
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| Final Effectiveness Findings |
The primary effectiveness hypothesis was the rate of technical placement success (i.e., deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration) and 12-month rate of freedom from new symptomatic PE while the filter is indwelling. Technical placement failure was reported for 4 patients (1.2%, n=324) and new symptomatic PE while the filter was indwelling was reported for 3 patients (0.93%, n=324). The primary effectiveness rate at 12 months for the Celect stratum was 97.8% (317/324; 95% CI: 95.6%, 99.1%), which was statistically greater (p < 0.0001) than the PG of 90%.
The secondary endpoints specified the rate of technical placement success and freedom from new symptomatic PE while the filter is indwelling. The rate for the Celect stratum was 97.8% (317/324), the rate for the Günther Tulip stratum was 98.7% (147/149), and the rate for the combined patient population was 98.1% (464/473).
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| Study Strengths and Weaknesses |
Strengths of the study include its prospective nature and assessment of real-world device performance in a broad patient population reflective of the patient population treated with filters in contemporary medical practice. Additionally, study design strengths included the objective primary and secondary endpoints, pre-specified imaging follow-up with independent core laboratory assessment of imaging-based endpoints, and long-term follow-up for indwelling filters. The study enrolled a low percentage of ethnic minority patients (in particular, Asian or Hispanic or Latino), though this may reflect real-world treatment practices at the study sites.
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| Recommendations for Labeling Changes |
Applicable safety and effectiveness findings reported in the final report for the IDE study should be added to the device labeling in a future submission.
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