N/A Completed N=129 Treatment

Celect Vena Cava Filter Clinical Trial

Chronic Obstructive Pulmonary Disease · Venous Thromboembolism

Source: ClinicalTrials.gov NCT00470626 ↗

Enrolled (actual)

129

Serious AEs

2.3%

Results posted

Apr 2010

Primary outcomePrimary: Major Adverse Event — 0; 1; 2; 0 participants

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.