N/A
N=129
Celect Vena Cava Filter Clinical Trial
Pulmonary Embolism · Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT00470626 ↗Enrolled (actual)
129
Serious AEs
2.3%
Results posted
Apr 2010
Primary outcome: Primary: Major Adverse Event — 0; 1; 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Celect Vena Cava Filter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Group Incorporated
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Event |
0; 1; 2; 0; 0; 0 | — |
| SECONDARY Successful Retrieval |
56 | — |
| SECONDARY Mean Time to Retrieval Attempt |
186 | — |
Summary
The clinical study will collect data to verify the safety and performance of the Cook Celect Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent high risk of thromboembolism.
Eligibility Criteria
Inclusion Criteria
- The patient is at high risk for pulmonary embolism and is under consideration for placement of a permanent or short-term IVC filter.
- The patient must have a patent internal jugular vein.
- The patient or guardian must have given informed consent.
- The patient must agree to return for clinical imaging follow-up at 1, 3, 6, and 12 months.
- The patient must agree to have a clinical and imaging examination performed prior to filter retrieval.
- The patient must agree to return for clinical and imaging follow-up at 30 days and 3 months after filter retrieval.
Exclusion Criteria
- The patient is less than 18 years of age.
- The patient is pregnant.
- The patient has uncontrollable coagulopathy.
- The patient has a life expectancy less than 6 months.
- The patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
- The patient's vena cava diameter is less than 15 mm, measured by vena cava sizing catheters.
- The patient has a contrast allergy that can not be adequately pre-medicated.
- The patient is simultaneously participating in another investigative drug or device study, or has a previous IVC filter.
Data sourced from ClinicalTrials.gov (NCT00470626). 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.